Tracers / [68Ga]Ga-DOTATATE
[68Ga]Ga-DOTATATE
Also written as [68Ga]DOTATATE; [68Ga]Ga-DOTA-TATE; [68Ga]Ga-DOTATATE; [Ga-68]DOTATATE; [Ga-68]Ga-DOTA-TATE; [Ga-68]Ga-DOTATATE; DOTA-(Tyr3)-octreotate
- Radionuclide
- Ga-68 t½ 67.7 min
- Modality
- PET
- Production route
- Generator / Cyclotron solid target
- Stage
- Approved
- Syntheses indexed
- 94
What it is
- Compound class
- Peptide (somatostatin analogue)
- Target / mechanism
- Somatostatin receptor subtype 2 (SSTR2) PMID 28547177 / DOI 10.1007/s00259-017-3728-y
- Clinical application
- Neuroendocrine neoplasms (diagnosis, staging, selection for PRRT); also SSTR-expressing meningioma PMID 28547177 / DOI 10.1007/s00259-017-3728-y; PMC11445317 (EANM/EANO/RANO/SNMMI meningioma SSTR-ligand guideline v1.0)
- Theranostic pair
- <a href="/tracers/lu177-dotatate/">lu177-dotatate</a>
Regulatory status
- FDA
- Yes — 2016; NETSPOT (kit for gallium Ga 68 dotatate); Advanced Accelerator Applications USA (Novartis); NDA 208547 Drugs@FDA, NDA 208547, approved 2016-06-01 — https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&searchTerm=dotatate
- EMA (centralised)
- No EMA medicines register — no centrally authorised gallium (68Ga) dotatate / oxodotreotide; search: https://www.ema.europa.eu/en/medicines?search_api_fulltext=gallium+dotatate
- Other approvals
- —
- Brand names
- NETSPOT (US, FDA)
Clinical use
- Typical injected activity
- 100-200 MBq (~2 MBq/kg; EANM guideline) PMID 28547177 / DOI 10.1007/s00259-017-3728-y
- Uptake time
- 45-90 min post-injection (typically 60 min) PMID 28547177 / DOI 10.1007/s00259-017-3728-y; PMID 31343614 / DOI 10.1097/MNM.0000000000001048
Reported in the literature. Not a dosing recommendation.
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| EasyOne Trasis | vendor cassette | SPE | 91 ± 5% yes | >99.3% | DOTATATE ABX | 41701433 2026 EJNMMI Radiopharm Chem [68Ga]Ga-DOTATATE was synthesized using Trasis EasyOne synthesizer as follows — The corrected yield of the labelled products was 91 ± 5% (72 ± 5% non-decay corrected). |
| Modular-Lab Standard Eckert & Ziegler | fixed tubing | SPE | 84.4±1.2% no | 99.1±0.3% | DOTA-TATE piCHEM, Raaba-Grambach, Austria | 39050235 2024 Asia Ocean J Nucl Med Biol Automated radiosynthesis module (Modular-Lab Standard) was from Eckert & Ziegler, Germany. — [68Ga]Ga-DOTATATE were found to be...(84.4±1.2)% (n=504) |
| — | — | — | — | — | — | 29747035 2018 Nucl Med Biol [18F]FDG and [68Ga]Ga-DOTATATE were obtained from the UCLA Biomedical Cyclotron Facility. |
| — | — | none | 99%±1% | higher than 98% | DOTATATE Bachem, Bubendorf, Switzerland | 26702783 2016 Nucl Med Biol |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | SPE | 87.9±0.4% | above 99.5% | DOTATATE (DOTA-(Tyr3)-octreotate) AUSPEP | 27408863 2014 Asia Ocean J Nucl Med Biol Eckert & Ziegler Eurotope's Modular-Lab Pharm Tracer® automated synthesis system — Ga-68 DOTATATE yields for 2011, 2012, and 2013 were 81.8±0.4%, 82.2±0.4% and 87.9±0.4%, respectively. |
| FASTlab GE HealthCare | — | SPE | 67.81±3.12 yes | 99.68±0.13 | DOTATATE ABX | 25369268 2014 PLoS One Most of the synthesis was performed using an automated process programmed in a FastLab module (General Electric Healthcare). — the decay-corrected radiochemical yield (%) was 54.03±2.45, 66.13±3.35 and 67.81±3.12 |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | 63.66% (mean); 63.34%, 63.71%, 64.01% | 99.45%, 99.78%, 99.75% | DOTATATE ABX | 33642752 2020 Indian J Nucl Med fully automated module (Scintomics GRP®, Fürstenfeldbruck, Germany) specifically designed for the synthesis of radiopharmaceuticals — Our validation runs of Ga-68-DOTATATE have demonstrated highly reproducible synthesis yields (mean value 63.66%). |
| AllinOne (AiO) Trasis | vendor cassette | SPE | 66% ± 5% yes | 98.4% ± 0.9% | DOTATATE AUSPEP | 35906092 2023 J Nucl Med performed on an AllInOne automated module (TRASIS), as shown in Figure 2 — for a global decay-corrected yield of 66% ± 5% (n = 14) |
| Modular-Lab (model not stated) Eckert & Ziegler | — | — | — | — | DOTATATE AUSPEP | 35906092 2023 J Nucl Med fractionized with the Eckert and Ziegler module in the clean room |
| — | — | — | — | — | — | 42620272 2026 Front Endocrinol (Lausanne) |
| — | — | — | — | — | — | 42454478 2026 Endocr Relat Cancer |
| — | — | — | — | — | — | 42311579 2026 Ochsner J |
| — | — | — | — | — | — | 42272569 2026 Case Rep Endocrinol |
| — | — | — | — | — | — | 42141279 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 42094219 2026 Cureus |
| — | — | — | — | — | — | 42077462 2026 Front Endocrinol (Lausanne) |
| — | — | — | — | — | — | 41994760 2026 Cureus |
| — | — | — | — | — | — | 41938633 2026 Clin Case Rep |
| — | — | — | — | — | — | 41938288 2026 AACE Endocrinol Diabetes |
| — | — | — | — | — | — | 41886137 2026 Curr Treat Options Oncol |
| — | — | — | — | — | — | 41872999 2026 Diabetes Obes Metab |
| — | — | — | — | — | — | 41767199 2026 JCEM Case Rep |
| — | — | — | — | — | — | 41764704 2026 EJNMMI Res |
| Manual synthesis | — | SPE | 81 ± 3% yes | 99.8 ± 0.2% | DOTA-TATE Nanchang Tanzhen Biological Technology Co., Ltd., China | 41764676 2026 EJNMMI Radiopharm Chem Radiolabeling of 68Ga with DOTA-TATE, Pentixafor and FAP-2286 was performed manually using a similar operating procedure — 81 ± 3% |
| — | — | — | — | — | — | 41757383 2026 J Diabetes Metab Disord |
| — | — | — | — | — | — | 41730635 2026 AJNR Am J Neuroradiol |
| — | — | — | — | — | — | 41704395 2026 Case Rep Endocrinol |
| EasyOne Trasis | vendor cassette | SPE | 90.95 yes | >99.7% | DOTATATE-peptide ABX | 41701433 2026 EJNMMI Radiopharm Chem [68Ga]Ga-DOTATATE was synthesized using Trasis EasyOne synthesizer — Yield %N/A90.95%90,32%91,06% |
| — | — | — | — | — | — | 41693498 2026 Nucl Med Commun |
| Manual synthesis | — | — | — | — | DOTATATE | 41515390 2025 Molecules The labeling process is carried out under controlled pH and temperature conditions to ensure a stable complexation between 68Ga and DOTA. — The reaction proceeds rapidly, with a high radiolabeling yield |
| — | — | — | — | — | — | 41375754 2025 J Clin Med |
| Modular-Lab Standard Eckert & Ziegler | vendor cassette | SPE | 89.03±3.78 | 98.69±1.24 | DOTATATE acetate ABX | 41370506 2025 Einstein (Sao Paulo) A Modular-Lab Standard synthesis module (Eckert & Ziegler, Berlin, Germany) was successfully installed and implemented in November 2013 — Labeling Yield (%)89.03±3.78 |
| — | — | — | — | — | — | 40563587 2025 Cancers (Basel) |
| — | — | — | — | >95 % | DOTATATE NetSpot | 40404554 2025 Diagn Interv Imaging |
| — | — | — | — | — | — | 40011184 2025 Urol Oncol |
| — | — | — | — | — | — | 39966364 2025 Curr Radiopharm |
| Manual synthesis | — | SPE | — | >99% | DOTA-TATE | 39770488 2024 Pharmaceuticals (Basel) During the labeling process, the generator was rinsed with 2 mL of 0.05 M HCl, and the waste solution was discarded. |
| — | — | — | — | — | — | 39351526 2024 Front Endocrinol (Lausanne) |
| — | — | — | — | — | — | 39327017 2024 J Nucl Med |
| Manual synthesis | — | HPLC | — | >96 % | DOTA-TATE Bachem, Bubendorf, Switzerland | 39310112 2024 Theranostics Radiolabeling of SSTR2 ligands with gallium‑68 and copper‑64 was performed in ammonium acetate buffer (2.0 mol/L, pH 4.5 and pH 5.3, respectively) at 80 °C for 20 min. |
| — | — | — | — | — | — | 39142828 2024 J Nucl Med |
| Modular-Lab Standard Eckert & Ziegler | fixed tubing | SPE | 84.4±1.2% no | 99.1±0.3% | DOTA-TATE piCHEM, Raaba-Grambach, Austria | 39050235 2024 Asia Ocean J Nucl Med Biol Automated radiosynthesis module (Modular-Lab Standard) was from Eckert & Ziegler, Germany. — [68Ga]Ga-DOTATATE were found to be ... (84.4±1.2)% (n=504) |
| — | — | — | — | — | — | 38787606 2024 FASEB J |
| — | — | — | — | — | — | 38341198 2024 BMJ Case Rep |
| — | — | — | — | — | — | 36714951 2023 Cancer Control |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | — | — | DOTATATE ABX | 35889351 2022 Molecules the automated synthesis module Scintomics GRPTM (Scintomics GmbH, Fürstenfeldbruck, Germany) |
| — | — | — | — | — | — | 34735669 2021 Curr Oncol Rep |
| — | — | — | — | — | — | 30854332 2019 Front Oncol |
| Manual synthesis | — | HPLC+SPE | 62% yes | >98% | DOTATATE In-house / non-commercial (various) | 29503845 2017 EJNMMI Radiopharm Chem heated in a microwave oven (catalog number: DMW7700WDB, Danby Appliance, Findlay, Ohio) — 61 ± 5, 62 ± 8 and 68 ± 13% respectively, n = 3 |
| — | — | — | — | — | — | 29072093 2018 Future Oncol |
| FASTlab GE HealthCare | — | SPE | 67.81 yes | 99.68 | DOTATATE ABX | 25369268 2014 PLoS One Most of the synthesis was performed using an automated process programmed in a FastLab module (General Electric Healthcare). — 67.8% for 68Ga-DOTATATE |
| Scintomics (model not stated) Scintomics | — | — | — | — | — | 24742330 2014 BMC Cancer 68Ga-DOTATOC/68Ga-DOTATATE was prepared using a modification of the method described by Breeman et al. [25] using a radiotracer synthesis module (Scintomics, Fürstenfeldbruck, Germany). |
| — | — | — | — | — | — | 23522791 2013 Appl Radiat Isot |
| — | — | — | 1.35 GBq | — | [68Ga]GaCl3 | 38447298 2024 Nucl Med Biol compatibility of the [68Ga]GaCl3 with NetSpot and Illuccix kits was investigated — 0.55 mL of buffer was added to 4.2 mL of [68Ga]GaCl3 which gave 1.35 GBq of formulated product |
| — | — | HPLC | — | — | DOTA-TATE | 37218205 2023 Curr Radiopharm |
| — | — | HPLC | 63.68 | 98 ± 0.22% | DOTATATE | 35190517 2022 Nucl Med Commun |
| — | — | — | 71 ± 5.8 % | >97 % | — | 40349649 2025 Appl Radiat Isot using the AllinOne 36-valve synthesis module — For [68Ga]Ga-DOTA-TATE, the yield was 71 ± 5.8 % with synthesis times about 18 min (n = 3) |
| — | — | — | — | — | DOTATATE | 23297077 2013 J Nucl Med Labeling of DOTANOC and DOTATATE with (68)Ga was standardized using a fully automated synthesis device. |
| — | — | — | — | — | — | 41202074 2026 Clin Nucl Med |
| — | — | — | — | — | — | 41006727 2025 Med Oncol |
| — | — | — | — | — | — | 26201091 2015 J Labelled Comp Radiopharm |
| — | — | — | — | — | — | 25977461 2015 J Nucl Med |
| — | — | — | — | — | — | 24120219 2014 Nucl Med Biol using a SCINTOMICS GRP module and an iThemba Labs generator |
| — | — | none | greater than 80% | — | DOTATATE | 22755505 2012 Bioconjug Chem The NaCl method was further evaluated using an automated fluid handling system — radiochemical yields greater than 80% |
| — | — | — | — | — | — | 22336375 2012 Nucl Med Biol |
| — | — | — | >70% | — | DOTA-TATE | 31421441 2019 Nucl Med Biol [68Ga]Ga-DOTA-TATE labelling was incorporated to give 1.56 GBq at EOS of the labelled peptide — RCY of >70% |
| — | — | — | — | — | — | 31058910 2019 J Vis Exp Radiolabeling of 68Ga-DOTATATE is performed with a fully automated labeling module coupled to a germanium-68 (68Ge)/68Ga generator. |
| — | — | — | >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%. |
| — | — | — | — | — | — | 42560334 2026 Radiat Prot Dosimetry |
| — | — | — | — | — | — | 42544987 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42526976 2026 Clin Lab Med |
| — | — | — | — | — | — | 42333414 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42276784 2026 J Nucl Med |
| — | — | — | — | — | — | 42264967 2026 Semin Nucl Med |
| — | — | — | — | — | — | 42257558 2026 Clin Nucl Med |
| — | — | — | 75.9 ± 1.8% | — | DOTA-TATE | 42229087 2026 Nucl Med Biol Manual [68Ga]Ga-DOTA-TATE labeling — Manual [68Ga]Ga-DOTA-TATE labeling yield increased from 58.9 ± 6% to 75.9 ± 1.8% (n = 10). |
| — | — | — | — | — | — | 42018345 2026 Clin Exp Rheumatol |
| — | — | — | — | — | — | 41984869 2026 Clin Nucl Med |
| — | — | — | — | — | — | 41894584 2026 Clin Nucl Med |
| — | — | — | — | — | — | 41869937 2026 Mol Imaging Radionucl Ther |
| — | — | — | — | — | — | 41849846 2026 Surgery |
| — | — | — | — | — | — | 41774422 2026 Ann Nucl Med |
| — | — | — | — | — | — | 41699279 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 41666059 2026 IEEE Trans Biomed Eng |
| — | — | — | — | — | — | 41627301 2026 Clin Nucl Med |
| — | — | — | — | — | — | 41545070 2026 J Nucl Med |
| — | — | — | — | — | — | 41506740 2026 Zhonghua Nei Ke Za Zhi |
| — | — | — | — | — | DOTA-TATE | 40883440 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 40762797 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 40259061 2025 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 39266292 2024 J Nucl Med |
| — | — | — | — | — | — | 38878175 2024 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 32293704 2020 Endokrynol Pol |
| — | — | — | — | — | — | 31302632 2020 J Nucl Med |
Precursor
- Common precursor
- DOTATATE peptide PMID 35418569 / DOI 10.1038/s41598-022-09590-2
- Suppliers seen in the literature
- DOTA-(Tyr3)-octreotate (DOTATATE) acetate salt from Bachem (Bubendorf, Switzerland)
- Cited suppliers in indexed syntheses
- ABX, AUSPEP, Bachem, Bubendorf, In-house / non-commercial (various), Nanchang Tanzhen Biological Technology Co., Ltd., NetSpot, piCHEM
- Typical final purification
- SPE
Need this precursor?We can point you to suppliers for [68Ga]Ga-DOTATATE, or handle the enquiry for you.
Get in touchQuality control Pharmacopoeial monograph
- Ph. Eur. monograph
- 3050
- USP monograph
- not verified — the USP-NF monograph index is subscription-only and no public confirmation was found
How this set was arrived at. Base set per Ph. Eur. 0125 + monograph 3050. Ge-68 breakthrough + metal impurities: generator Ga-68 only. RECOMMEND ADD: molar activity / peptide content (saturable somatostatin-receptor target).
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 [68Ga]Ga-DOTATATE.
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