Tracer library / [177Lu]Lu-DOTATATE
Structure of DOTATATE (unlabelled parent compound, from PubChem)
Unlabelled parent compoundPubChem CID 11170867

[177Lu]Lu-DOTATATE

Also written as 177Lu-DOTA-TATE; [177Lu]Lu-DOTA-TATE; [177Lu]Lu-DOTATATE; [Lu-177]Lu-DOTATATE; DOTA-TATE; lutetium (177Lu) oxodotreotide
Radionuclide
Lu-177 t½ 9585 min
Modality
Therapy
Production route
—
Stage
Approved
Syntheses indexed
10
Peptide receptor radionuclide therapyNeuroendocrine neoplasms

What it is

Compound class
DOTA-conjugated somatostatin analogue (radiolabelled peptide, octreotate)
Target / mechanism
Targets somatostatin receptor subtype 2 (SSTR2) PMID 39142827
Clinical application
Peptide receptor radionuclide therapy (PRRT) for somatostatin receptor-positive tumours, including neuroendocrine tumours and meningiomas PMID 40177560
Theranostic pair
[68Ga]Ga-DOTATATE

Regulatory status

FDA
Yes — 2018; Lutathera (lutetium Lu 177 dotatate); sponsor AAA USA INC; NDA 208700 Drugs@FDA / openFDA drug registry, NDA 208700, original approval 2018-01-26, marketing status 'Prescription' — https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA208700%22 (queried 2026-09-18)
EMA (centralised)
Yes — 2017; Lutathera (lutetium (177Lu) oxodotreotide); Novartis Europharm Limited; EMEA/H/C/004123 EMA medicines register (JSON export 2026-09-18), EPAR Lutathera: status 'Authorised', marketing authorisation date 2017-09-26 — https://www.ema.europa.eu/en/medicines/human/EPAR/lutathera
Other approvals
—
Brand names
—

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
Modular-Lab PharmTracer
Eckert & Ziegler
vendor cassetteSPE80%99.8 ± 0.05%
(ITLC); 97.3 ± 1.5% (HPLC)
DOTA-(Tyr3)-octreotate
AUSPEP
27408890
2015 Asia Ocean J Nucl Med Biol
Eckert & Ziegler Eurotope’s Modular-Lab Pharm Tracer® automated synthesis system - an estimate of 80% synthesis yield
Manual synthesis————DOTATATE
Bachem, Bubendorf, Switzerland
42518020
2026 EJNMMI Res
[177Lu]Lu-DOTATATE was radiolabelled as previously described by Lundsten et al. [28], using the same conditions as mentioned above.
iPHASE MultiSyn
iPHASE Technologies
vendor cassette—98 ± 3%
not corrected
95.2 ± 1.3%
0h HPLC
DOTA-TATE
Huayi
40696084
2025 EJNMMI Radiopharm Chem
This process was automated using an iPHASE MultiSyn radiochemistry module with sterile kits affording sterile and apyrogenic 177Lu-labeled radiopharmaceuticals in non-decay corrected yields > 95%. - The yield for this radiopharmaceutical was 98 ± 3%.
Manual synthesis———>95%DOTATATE
AUSPEP
40147849
2025 J Nucl Med
Radiolabeling of the DOTA compounds was done at 85°C for 25 min, using ascorbic acid buffer and no-carrier-added [177Lu]LuCl3
Manual synthesis—HPLC—>96 %DOTA-TATE
Bachem, Bubendorf, Switzerland
39310112
2024 Theranostics
Radiolabeling with lutetium‑177 and copper‑67 was performed in sodium ascorbate buffer (0.15 mol/L, pH 4.8) for 40 min, at 80 °C and 40 °C, respectively.
Manual synthesis—none—>98%DOTATATE
Bachem, Bubendorf, Switzerland
39046521
2024 Eur J Nucl Med Mol Imaging
DOTA-LM3 (CSBio, Silicon Valley Menlo Park, California, United States) and DOTATATE (Bachem, Bubendorf, Switzerland) were labeled with terbium-161 or lutetium-177 at a molar activity of up to 100 MBq/nmol using standard labeling conditions as previously reported
———>97%>90%DOTA-TATE
Bachem, Bubendorf, Switzerland
36145306
2022 Pharmaceuticals (Basel)
———98%—DOTA-TATE40425733
2026 Nat Protoc
————>99%DOTATATE26443981
2016 Nucl Med Commun
novel, self-shielded modular radiosynthesis system for fully automated preparation of PET and therapeutic radiopharmaceuticals
Synthera
IBA
——>99%>99%—22149590
2012 Cancer Biother Radiopharm
reprogramming and adaptation of a commercially available synthetic module (IBA molecular; Synthera®) allowed high yield, fully automated, in-house radiolabeling - (68)Ga-octreotate and (177)Lu-octreotate were synthesized, resulting in both radiochemical yield and radiochemical purity greater than 99%.

Clinical literature

Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.

  1. [177Lu]Lu-DOTATATE for Recurrent Meningioma (LUMEN-1, EORTC-2334-BTG): Study Protocol for a Randomized Phase II Trial.
    2026 · J Nucl Med · Prospective, multicentre · Phase II
  2. Dosimetry-guided peptide receptor radionuclide therapy in neuroendocrine tumors: interim safety analysis of the DUONEN trial.
    2025 · Front Endocrinol (Lausanne) · Prospective, multicentre · Phase III
  3. Multicentric Matched-Pair Analysis of Long-Term Hematotoxicity of Peptide Receptor Radionuclide Therapy in Patients Postsplenectomy.
    2025 · J Nucl Med · Retrospective, multicentre
  4. Somatostatin analogue continuation upon progression in patients with gastroenteropancreatic neuroendocrine tumour (SAUNA trial): a randomised controlled trial protocol.
    2025 · BMJ Open · Multicentre
  5. PRRT plus holmium-166-SIRT (HEPAR PLuS) versus PRRT-only in patients with metastatic neuroendocrine tumors: A propensity-score matched analysis.
    2025 · J Neuroendocrinol · Retrospective, multicentre
  6. Peptide Receptor Radionuclide Therapy or Everolimus in Metastatic Neuroendocrine Tumors: The SeqEveRIV Study, a National Study from the French Group of Endocrine Tumors and Endocan-RENATEN Network.
    2024 · J Nucl Med · Retrospective, multicentre
  7. A Phase II Trial of a Personalized, Dose-Intense Administration Schedule of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-Risk Neuroblastoma-LuDO-N.
    2022 · Front Pediatr · Multicentre · Phase II
  8. Effect of peptide receptor radionuclide therapy (PRRT) with tandem isotopes - [90Y]Y/[177Lu]Lu-DOTATATE in patients with disseminated neuroendocrine tumours depending on [18F]FDG PET/CT qualification in Polish multicentre experience - do we need [18F]FDG PET/CT for qualification to PRRT?
    2020 · Endokrynol Pol · Multicentre
  9. Preliminary Evaluation of 225 Ac/ 177 Lu-DOTATATE PRRT in Progressive Meningiomas : Efficacy, Dosimetry, and Imaging Insights.
    2026 · Clin Nucl Med · Prospective
  10. PReCedeNT trial: Phase III randomized-controlled trial of Lutetium - 177 DOTATATE Peptide Receptor Radionuclide Therapy (PRRT) plus Chemotherapy versus PRRT alone in FDG-avid, Well-differentiated Gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
    2025 · BMC Cancer · Prospective · Phase III
Show all 117 clinical studies
  1. The Polish radioligand therapy (RLT) Registry: initial real-world evidence in neuroendocrine tumors.
    2025 · Nucl Med Rev Cent East Eur · Prospective, retrospective
  2. Adverse Events of Radioligand Therapy in Patients with Progressive Neuroendocrine Neoplasms: The Biggest Eastern European Prospective Study.
    2024 · Cancers (Basel) · Prospective
  3. Efficacy and Safety of 225 Ac-DOTATATE in the Treatment of Neuroendocrine Neoplasms With High SSTR Expression.
    2024 · Clin Nucl Med · Prospective
  4. Prediction of 177Lu-DOTATATE PRRT Outcome Using Multimodality Imaging in Patients with Gastroenteropancreatic Neuroendocrine Tumors: Results from a Prospective Phase II LUMEN Study.
    2024 · J Nucl Med · Prospective · Phase II
  5. Peptide receptor radionuclide therapy implementation and results in a predominantly gastrointestinal neuroendocrine tumor population: A two-year experience in a nonuniversity setting.
    2022 · Medicine (Baltimore) · Prospective
  6. Clinical Assessment of 177Lu-DOTATATE Quantification by Comparison of SUV-Based Parameters Measured on Both Post-PRRT SPECT/CT and 68Ga-DOTATOC PET/CT in Patients With Neuroendocrine Tumors: A Feasibility Study.
    2021 · Clin Nucl Med · Prospective
  7. Analysis of outcome in patients with different primary localisation of neuroendocrine tumors after PRRT. 10 years single institution experience.
    2026 · Hell J Nucl Med · Retrospective
  8. Optimization of Gravity Infusion Protocols for 177Lu-DOTATATE Administration in Peptide Receptor Radionuclide Therapy.
    2026 · Pharmaceutics · Retrospective
  9. Peptide receptor radionuclide therapy with 177Lu-DOTATATE: A retrospective evaluation of the experience at the Department of Nuclear Medicine at Theageneio Cancer Hospital.
    2026 · Hell J Nucl Med · Retrospective
  10. Targeted Alpha Therapy With [ 225 Ac]Ac-DOTATATE Versus Salvage Retreatment PRRT With [ 177 Lu]Lu-DOTATATE in Progressive Metastatic Neuroendocrine Tumor Patients After Initial Course of [ 177 Lu]Lu-DOTATATE Treatment : An Observational Study Comparing the Therapeutic Response, Survival, and Clinical Toxicity.
    2026 · Clin Nucl Med · Retrospective
  11. Efficacy of intra-arterial [ 177 Lu]Lu-DOTATATE vs. continuation intravenous [ 177 Lu]Lu-DOTATATE peptide receptor radionuclide therapy in nonresponding locally advanced inoperable or liver-dominant metastatic gastroenteropancreatic neuroendocrine tumors.
    2026 · Nucl Med Commun · Retrospective
  12. Semiquantitative SSTR PET metrics show molecular-morphologic discordance after 177Lu-DOTATATE in gastroenteropancreatic neuroendocrine neoplasms: an exploratory paired target-lesion analysis.
    2026 · Ann Nucl Med · Retrospective
  13. Estimation of split renal function on PET using the SSTR-targeting radioligands [18F]SiTATE, [68Ga]Ga-DOTA-TATE and [68Ga]Ga-DOTA-TOC in a theranostic setting.
    2026 · Eur J Nucl Med Mol Imaging · Retrospective
  14. Predicting eligibility for outpatient 177 Lu-DOTATATE-targeted radionuclide therapy in patients with neuroendocrine tumors.
    2026 · Nucl Med Commun · Retrospective
  15. Quantitative indices from post-PRRT SPECT/CT: an exploratory approach to early imaging biomarkers in neuroendocrine tumors.
    2026 · Jpn J Radiol · Retrospective
  16. Outcomes of Peptide Receptor Radionuclide Therapy with 177Lu-DOTATATE in Patients with Metastatic Pheochromocytoma and Paraganglioma.
    2026 · J Nucl Med · Retrospective
  17. Sex-dependent PRRT toxicity in patients with metastatic somatostatin receptor-avid neuroendocrine tumors treated with 177Lu-DOTATATE.
    2026 · Hormones (Athens) · Retrospective
  18. Normal organ [68Ga]DOTATOC uptake during PRRT: challenging the assumption of stable background shaped by cold somatostatin analogues treatment.
    2026 · Eur J Nucl Med Mol Imaging · Retrospective
  19. Peptide receptor radionuclide therapy alone or in combination with temozolomide plus/minus capecitabine in [18F]FDG-positive metastatic neuroendocrine tumors.
    2026 · Eur J Nucl Med Mol Imaging · Retrospective
  20. Anatomical-biochemical discordance and prognostic role of bone metastases in advanced MTC treated with [¹⁷⁷Lu]Lu-DOTA-TATE.
    2025 · BMC Cancer · Retrospective
  21. Peptide Receptor Radionuclide Therapy with Lu-177-DOTATATE and Monitoring with Somatostatin Receptor PET/CT in Patients with Advanced Differentiated Thyroid Carcinoma.
    2025 · Mol Imaging Biol · Retrospective
  22. Imaging-derived biomarkers from 68Ga-DOTATOC PET/CT scans to predict survival of patients with neuroendocrine tumors after PRRT with 177Lu-DOTATATE.
    2025 · Cancer Imaging · Retrospective
  23. Association of integrated biomarkers and progression-free survival prediction in patients with gastroenteropancreatic neuroendocrine tumors undergoing [177Lu]Lu-DOTA-TATE therapy.
    2025 · Theranostics · Retrospective
  24. Predictive factors for persistent thrombocytopenia after peptide receptor radioligand therapy in enteropancreatic neuroendocrine tumors.
    2025 · Front Endocrinol (Lausanne) · Retrospective
  25. Peptide receptor radionuclide therapy in malignant insulinoma.
    2025 · Endocr Relat Cancer · Retrospective
  26. Clinical Outcomes of 177Lu-DOTATATE Peptide Receptor Radionuclide Therapy in Patients with Skeletal Metastases from Neuroendocrine Tumors: Insights from Real-World Experience.
    2025 · J Nucl Med · Retrospective
  27. Safety and Efficacy of Peptide Receptor Radionuclide Therapy in Multiple Endocrine Neoplasia Syndrome: A Single-center Experience.
    2025 · Clin Nucl Med · Retrospective
  28. Pre-treatment 111In-pentetreotide SPECT/CT vs. baseline 177Lu-DOTATATE SPECT/CT: are there differences in lesion uptake and detectability?
    2025 · Ann Nucl Med · Retrospective
  29. Full-Body Tumor Response Heterogeneity of Metastatic Neuroendocrine Tumor Patients Undergoing Peptide Receptor Radiopharmaceutical Therapy.
    2025 · J Nucl Med · Retrospective
  30. Prognostic value of interim [68Ga]Ga-DOTA-TOC PET/CT in patients with neuroendocrine tumour who underwent peptide receptor radionuclide therapy.
    2025 · Eur Radiol · Retrospective
  31. Outcome of 177Lu-DOTATATE Peptide Receptor Radionuclide Therapy in Progressive Metastatic Neuroendocrine Tumors from a Tertiary Care Center.
    2024 · Indian J Endocrinol Metab · Retrospective
  32. Time toxicity of lutetium 177 in gastroenteropancreatic neuroendocrine tumours.
    2024 · Endocr Oncol · Retrospective
  33. Spleen Volume Reduction Is a Reliable and Independent Biomarker for Long-Term Risk of Leukopenia Development in Peptide Receptor Radionuclide Therapy.
    2024 · J Nucl Med · Retrospective
  34. Enhancing precision: A predictive model for 177Lu-DOTATATE treatment response in neuroendocrine tumors using quantitative 68Ga-DOTATATE PET and clinicopathological biomarkers.
    2024 · Theranostics · Retrospective
  35. Mid-Treatment Response to 177-Lutetium Dotatate Predicts Overall Outcome in Patients With Advanced Neuroendocrine Tumors.
    2024 · JCO Oncol Pract · Retrospective
  36. Peptide receptor radionuclide therapy with 177Lu- or 90Y-SSTR peptides in malignant pheochromocytomas (PCCs) and paragangliomas (PGLs): results from a single institutional retrospective analysis.
    2024 · Endocrine · Retrospective
  37. Efficacy, Toxicity, and Prognostic Factors of Re-treatment With [177Lu]Lu-DOTA-TATE in Patients With Progressing Neuroendocrine Tumors: The Experience of a Single Center.
    2023 · Cureus · Retrospective
  38. Impact of administered amount of peptide on tumor dosimetry at the first cycle of peptide receptor radionuclide therapy (PRRT) in relation to total tumor somatostatin receptor expression.
    2023 · EJNMMI Res · Retrospective
  39. The efficacy, toxicity and survival of salvage retreatment PRRT with 177Lu-DOTATATE in patients with progressive NET following initial course of PRRT.
    2022 · Br J Radiol · Retrospective
  40. Comparison of Choi, RECIST and Somatostatin Receptor PET/CT Based Criteria for the Evaluation of Response and Response Prediction to PRRT.
    2022 · Pharmaceutics · Retrospective
  41. Nephrotoxicity and hematotoxicity one year after four cycles of peptide receptor radionuclide therapy (PRRT) and its impact on future treatment planning - A retrospective analysis.
    2022 · Rev Esp Med Nucl Imagen Mol (Engl Ed) · Retrospective
  42. Efficacy and Safety of 177Lu-DOTATATE in Lung Neuroendocrine Tumors: A Bicenter study.
    2022 · J Nucl Med · Retrospective
  43. Haematotoxicity during peptide receptor radionuclide therapy: Baseline parameters differences and effect on patient's therapy course.
    2021 · PLoS One · Retrospective
  44. Twelve-Year Follow-up After Peptide Receptor Radionuclide Therapy.
    2019 · J Nucl Med · Retrospective
  45. Peptide Receptor Radionuclide Therapy in Grade 3 Neuroendocrine Neoplasms: Safety and Survival Analysis in 69 Patients.
    2019 · J Nucl Med · Retrospective
  46. Managing hematological toxicity in [¹⁷⁷Lu]Lu-DOTATATE for NET patients: a national survey from the French group of endocrine tumors (GTE) on the clinical need for harmonized monitoring strategies.
    2026 · Eur J Nucl Med Mol Imaging · Clinical study
  47. No-carrier-added 177Lu production eliminates persistent urine radioactivity: implications for safe expansion of targeted radionuclide therapy.
    2026 · Ann Nucl Med · Clinical study
  48. Current UK practice in [ 177 Lu]-DOTATATE peptide receptor radionuclide therapy: a national survey of national health service centres.
    2026 · Nucl Med Commun · Clinical study
  49. Molecular Deconvolution of Circulating "Other Cells": A Reliable Predictive Marker of Therapy Response and Survival in Neuroendocrine Tumor Patients Receiving 177Lu-DOTATATE PRRT.
    2026 · Cancer Med · Clinical study
  50. Predicting 177Lu-DOTATATE therapy response through immune microenvironment parameters in gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
    2026 · Eur J Nucl Med Mol Imaging · Clinical study
  51. Exceptional Response to Rechallenge Peptide Receptor Radionuclide Therapy in Metastatic Carotid Body Tumor.
    2026 · Clin Nucl Med · Clinical study
  52. Comparison of the averaged biodistribution and pharmacokinetics between [99mTc]Tc-HYNIC-TOC and [177Lu]Lu-DOTA-TATE in neuroendocrine tumor patients.
    2025 · Nucl Med Rev Cent East Eur · Clinical study
  53. Complete Radiologic Response After 177Lu-DOTATATE Therapy in Treatment of a Lung Metastatic Intracranial Atypical Meningioma.
    2025 · Clin Nucl Med · Clinical study
  54. Postmarketing safety surveillance of 177 Lu-DOTA-TATE (LUTATHERA): an observational, pharmacovigilance study leveraging FAERS database.
    2025 · Nucl Med Commun · Clinical study
  55. Revolutionizing Thyroid Cancer Treatment: Restoring Radioiodine Avidity After PRRT-A Case Series.
    2025 · Clin Nucl Med · Clinical study
  56. Cost-Effectiveness of [177Lu]Lu-DOTATATE for the Treatment of Newly Diagnosed Advanced Gastroenteropancreatic Neuroendocrine Tumors: An Analysis Based on Results of the NETTER-2 Trial.
    2025 · J Nucl Med · Clinical study
  57. Comparison of the Hematotoxicity of PRRT with Lutathera® and Locally Manufactured 177Lu-HA-DOTATATE in Patients with Neuroendocrine Tumors and the Impact of Different Application Intervals.
    2025 · Cancers (Basel) · Clinical study
  58. Long-term Efficacy, Survival, and Toxicity of Peptide Receptor Radionuclide Therapy in Patients With Refractory Meningioma.
    2025 · Clin Nucl Med · Clinical study
  59. Systemic effects of 177Lu-DOTATATE therapy to patients with metastatic neuroendocrine tumors: mechanistic insights and role of exosome.
    2025 · Eur J Nucl Med Mol Imaging · Clinical study
  60. Safety and dosimetry of [177Lu]Lu-DOTA-TATE in adolescent patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, or pheochromocytomas and paragangliomas: Primary analysis of the Phase II NETTER-P study.
    2025 · Eur J Nucl Med Mol Imaging · Clinical study · Phase II
  61. Factors and predictors affecting late external dose rates and isolation period in patients after lutetium-177-labeled DOTA-Tyr3-octreotate treatment for neuroendocrine tumors.
    2025 · Ann Nucl Med · Clinical study
  62. Neuroendocrine peritoneal disease and [177Lu]DOTATATE peptide receptor radionuclide therapy: a therapeutic challenge with potential clinical complications.
    2025 · Eur J Nucl Med Mol Imaging · Clinical study
  63. Feasibility and Safety of Peptide Receptor Radionuclide Therapy With 177 Lu-DOTATATE for Neuroendocrine Tumor in a Patient With Sickle Cell Anemia.
    2025 · Clin Nucl Med · Clinical study
  64. 177Lu-DOTATATE in Combination with PARP Inhibitor Olaparib Is Feasible in Patients with Somatostatin-Positive Tumors: Results from the LuPARP Phase I Trial.
    2025 · J Nucl Med · Clinical study · Phase I
  65. Targeted Peptide Receptor Radionuclide Therapy With 177 Lu-DOTATATE Alters Joints Inflammation.
    2025 · Clin Nucl Med · Clinical study
  66. Surgery enhances the effectiveness of peptide receptor radionuclide therapy in metastatic gastroenteropancreatic neuroendocrine tumors.
    2025 · Surgery · Clinical study
  67. Possible changes in glucose metabolism induced by radioligand therapy in patients with neuroendocrine neoplasms.
    2024 · Endokrynol Pol · Clinical study
  68. Case Series: ATRX Variants in Four Patients with Metastatic Pheochromocytoma.
    2024 · Front Endocrinol (Lausanne) · Clinical study
  69. Peptide Receptor Radionuclide Therapy in Advanced Refractory Meningiomas: Efficacy and Toxicity in a Long Follow-up.
    2024 · J Nucl Med · Clinical study
  70. The First Case of 99mTc-FAPI Uptake in Optic Nerve Sheath Meningioma.
    2024 · Clin Nucl Med · Clinical study
  71. Repeat Peptide Receptor Radionuclide Therapy in Neuroendocrine Tumors: A NET Center of Excellence Experience.
    2024 · J Gastrointest Cancer · Clinical study
  72. Safety and efficacy of peptide receptor radionuclide therapy in neuroendocrine tumors: A single center experience.
    2024 · PLoS One · Clinical study
  73. Absorbed Dose-Response Relationship in Patients with Gastroenteropancreatic Neuroendocrine Tumors Treated with [177Lu]Lu-DOTATATE: One Step Closer to Personalized Medicine.
    2024 · J Nucl Med · Clinical study
  74. Managing Catecholamine Release Syndrome During and Following Lu-177-DOTATATE in High-Risk Pheochromocytoma Patients.
    2024 · JCEM Case Rep · Clinical study
  75. Cutaneous Neuroendocrine Metastases of Visceral Origin Responsive to Surgical Resection and Targeted Radionuclide Therapy.
    2024 · Case Rep Dermatol Med · Clinical study
  76. Outcome on Mesenteric Mass Response of Small-Intestinal Neuroendocrine Tumors Treated by 177Lu-DOTATATE Peptide Receptor Radionuclide Therapy: The MesenLuth Study, a National Study from the French Group of Endocrine Tumors and Endocan-RENATEN Network.
    2024 · J Nucl Med · Clinical study
  77. Study protocol of LANTana: a phase Ib study to investigate epigenetic modification of somatostatin receptor-2 with ASTX727 to improve therapeutic outcome with [177Lu]Lu-DOTA-TATE in patients with metastatic neuroendocrine tumours, UK.
    2023 · BMJ Open · Clinical study · Phase I
  78. Feasibility and therapeutic potential of the 68Ga/177Lu-DOTATATE theranostic pair in patients with metastatic medullary thyroid carcinoma.
    2023 · Ann Endocrinol (Paris) · Clinical study
  79. Amino acid extravasation: a rare red flag to keep in mind during peptide receptor radioligand therapy (PRRT) with [177Lu]Lu-DOTATATE.
    2022 · Nucl Med Rev Cent East Eur · Clinical study
  80. Evaluation of Liver and Renal Toxicity in Peptide Receptor Radionuclide Therapy for Somatostatin Receptor Expressing Tumors: A 2-Year Follow-Up.
    2022 · Oncologist · Clinical study
  81. Hepatic complications of peptide receptor radionuclide therapy with Lutetium-177 and Yttrium-90 in patients with neuroendocrine neoplasm.
    2022 · Nucl Med Rev Cent East Eur · Clinical study
  82. Feasibility and Therapeutic Potential of Combined Peptide Receptor Radionuclide Therapy With Intensive Chemotherapy for Pediatric Patients With Relapsed or Refractory Metastatic Neuroblastoma.
    2021 · Clin Nucl Med · Clinical study
  83. Laboratory, Clinical, and Survival Outcomes Associated With Peptide Receptor Radionuclide Therapy in Patients With Gastroenteropancreatic Neuroendocrine Tumors.
    2021 · JAMA Netw Open · Clinical study
  84. 131I-MIBG negative progressive symptomatic metastatic paraganglioma: response and outcome with 177Lu-DOTATATE peptide receptor radionuclide therapy.
    2021 · Ann Nucl Med · Clinical study
  85. Initial experience and lessons learned with implementing Lutetium-177-dotatate radiopharmaceutical therapy in a radiation oncology-based program.
    2021 · Brachytherapy · Clinical study
  86. One decade of 'Bench-to-Bedside' peptide receptor radionuclide therapy with indigenous [177Lu]Lu-DOTATATE obtained through 'Direct' neutron activation route: lessons learnt including practice evolution in an Indian setting.
    2020 · Am J Nucl Med Mol Imaging · Clinical study
  87. Pre-therapy Somatostatin Receptor-Based Heterogeneity Predicts Overall Survival in Pancreatic Neuroendocrine Tumor Patients Undergoing Peptide Receptor Radionuclide Therapy.
    2019 · Mol Imaging Biol · Clinical study
  88. Effectiveness of radiolabelled somatostatin analogues (90Y-DOTATOC and 177Lu-DOTATATE) in patients with metastatic neuroendocrine tumours: a single centre experience in Mexico.
    2017 · Rev Esp Med Nucl Imagen Mol · Clinical study
  89. Theranostic Applications of Lutetium-177 in Radionuclide Therapy.
    2016 · Curr Radiopharm · Clinical study
  90. DNA damage in blood lymphocytes in patients after (177)Lu peptide receptor radionuclide therapy.
    2015 · Eur J Nucl Med Mol Imaging · Clinical study
  91. Treatment with tandem [90Y]DOTA-TATE and [177Lu]DOTA-TATE of neuroendocrine tumours refractory to conventional therapy.
    2014 · Eur J Nucl Med Mol Imaging · Clinical study · Phase II
  92. Radiolabeled somatostatin analogues therapy in advanced neuroendocrine tumors: a single centre experience.
    2012 · J Oncol · Clinical study
  93. PET SUV correlates with radionuclide uptake in peptide receptor therapy in meningioma.
    2012 · Eur J Nucl Med Mol Imaging · Clinical study
  94. Diffusely Increased Bone Marrow Uptake on DOTATATE PET/CT Due to PRRT-related Myelodysplasia Syndrome.
    2026 · Clin Nucl Med · Case report
  95. Gallbladder Neuroendocrine Tumor and 177 Lu DOTATATE: High Somatostatin Receptor Expression Without Clinical Response.
    2026 · Clin Nucl Med · Case report
  96. Success of 177Lu-DOTATATE therapy in a metastatic pituitary neuroendocrine tumor.
    2025 · Endocr Oncol · Case report
  97. Potentially fatal crisis after 177Lu-DOTATATE therapy for paraganglioma: a case report with review of literature.
    2025 · Endocr J · Case report
  98. An ACTH-Producing Neuroendocrine Tumor: Clinical Course of Multidisciplinary Therapy Including Peptide Receptor Radionuclide Therapy - A Case Report.
    2025 · Case Rep Oncol · Case report
  99. Heterogeneous SSTR2 target expression and a novel KIAA1549::BRAF fusion clone in a progressive metastatic lesion following 177Lutetium-DOTATATE molecular radiotherapy in neuroblastoma: a case report.
    2024 · Front Oncol · Case report
  100. Choose Your Collimator Wisely: Inappropriate Collimator Selection During a 177Lu-DOTATATE Posttreatment Scan.
    2024 · J Nucl Med Technol · Case report
  101. Treatment of an Aggressive Gonadotroph Pituitary Neuroendocrine Tumor With 177Lutetium DOTATATE Radionuclide Therapy.
    2024 · JCEM Case Rep · Case report
  102. Sunitinib in Tandem With 177 Lu-DOTATATE Therapy in Advanced Pancreatic Neuroendocrine Tumor : A New Treatment Approach.
    2024 · Clin Nucl Med · Case report
  103. 177 Lu-DOTATATE (Lutathera) Therapy in 68 Ga-DOTATATE PET/CT-Negative Liver Metastases of a Neuroendocrine Tumor.
    2023 · Clin Nucl Med · Case report
  104. A rare case of poorly differentiated mixed neuroendocrine-nonneuroendocrine tumor of the caecum with long term survival: A case report.
    2022 · Endocr Regul · Case report
  105. Lutetium-177 Dotatate-Induced Hemolytic Anemia and Myelodysplastic Syndrome.
    2022 · Cureus · Case report
  106. Selective use of Peptide Receptor Radionuclide Therapy following comparative imaging of Ga-68 DOTATATE PET/CT against I-131 MIBG scintigraphy in a small Asian cohort of Adult Neuroblastoma.
    2021 · Med J Malaysia · Case report
  107. Significant impact of transient deterioration of renal function on dosimetry in PRRT.
    2013 · Ann Nucl Med · Case report

Precursor

Common precursor
—
Suppliers seen in the literature
—
Cited suppliers in indexed syntheses
AUSPEP, Bachem, Bubendorf, Huayi
Typical final purification
—

Need this precursor?We can point you to suppliers for [177Lu]Lu-DOTATATE, or handle the enquiry for you.

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Quality control Derived from the published synthesis

Ph. Eur. monograph
no monograph none for the Lu-177 finished product (general 0125 applies). NB: the Ga-68 analogue has monograph 3050
USP monograph
not verified the USP-NF monograph index is subscription-only and no public confirmation was found
AppearancepHRCP HPLCRCP TLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrityOsmolalityMolar activityMetal impuritiesLu-177m
How this set was arrived at. No Lu-177 monograph — base set per Ph. Eur. 0125 + rule-based (see Ga-68 analogue monograph 3050 for the ligand method). Lu-177m content + metal impurities + molar activity + osmolality per rules.

Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived

Setting up quality control?We can help you scope the equipment needed to release [177Lu]Lu-DOTATATE.

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Notes

Stage 8: Lutathera / [177Lu]Lu-DOTA-TATE. 2 corpus articles with Lu-177 (PMID 35966589, 35906092) were collapsed onto the Ga-68 anchor [68Ga]Ga-DOTATATE. Added as its own row. Theranostic hub: also paired (one-way) from cu64-dotatate, f18-fet-bag-toca -- ga68-dotatate (NETSPOT) is the FDA-approved companion diagnostic for Lu-177-DOTATATE (Lutathera); the other two are additional diagnostics paired with the same therapeutic in the literature. [stage 19] Compound class inferred from precursor name (not stated outright) -- PMID 27408890: 'DOTATATE, or DOTA-(Tyr3)-octreotate (where DOTA = 1,4,7,10-tetraazacyclododecane– 1,4,7, 10-tetraacetic acid) was obtained from Auspep (Melbourne, Australia)'. Stage set/updated at stage 23 from PMID 40696084: 'Lutetium-177 (177Lu) theranostics have revolutionized personalized cancer treatment, particularly with FDA-approved therapies like [177Lu]Lu-DOTA-TATE for neuroendocrine tumors and [177Lu]Lu-PSMA for prostate cancer.'.
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