Tracer library / [68Ga]Ga-FAPI-04
Structure of FAPI-04 (unlabelled parent compound, from PubChem)
Unlabelled parent compoundPubChem CID 138454803

[68Ga]Ga-FAPI-04

Also written as [68Ga]Ga-FAPI-04; [68Ga]Ga-FAPI-4; [Ga-68]Ga-FAPI-04; FAPI-04; Ga-68 FAPI-04
Radionuclide
Ga-68 t½ 67.71 min
Modality
PET
Production route
—
Stage
—
Syntheses indexed
6
Fibroblast activation / tumour stromaPan-cancer / multiple tumour types

What it is

Compound class
Radiolabelled quinoline-based FAP-inhibitor (small molecule, DOTA-conjugated)
Target / mechanism
Fibroblast activation protein (FAP), a serine protease overexpressed on cancer-associated fibroblasts PMID 30850501
Clinical application
Pan-cancer imaging of tumour-stroma/fibroblast activation (evaluated across 28 cancer types) PMID 30954939
Theranostic pair
[177Lu]Lu-FAPI-04

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
——SPE——DOTA-FAPI-04 precursor35991604
2022 Front Chem
Modular-Lab Standard
Eckert & Ziegler
fixed tubingSPE85.5±1.4%
not corrected
—DOTA-FAPI-4
MedChemExpress
39050235
2024 Asia Ocean J Nucl Med Biol
Automated radiosynthesis module (Modular-Lab Standard) was from Eckert & Ziegler, Germany. - The non-decay corrected (ndc) RCY for [68Ga]Ga-Pentixafor, [68Ga]Ga-FAPI-4 and [68Ga]Ga-DOTATATE were found to be...(85.5±1.4)% (n=9)
———90.2%96.5%FAPI-0442569132
2026 ACS Omega
FASTlab 2
GE HealthCare
custom manifoldnone—98.77 ± 0.12DOTA-FAPI-04
MedChemExpress
39598846
2024 Molecules
Automated labeling of the precursor was accomplished using a FASTLab 2 synthesizer.
Modular-Lab Standard
Eckert & Ziegler
fixed tubingSPE85.5±1.4%
not corrected
99.6±0.2%DOTA-FAPI-4
MedChemExpress
39050235
2024 Asia Ocean J Nucl Med Biol
Automated radiosynthesis module (Modular-Lab Standard) was from Eckert & Ziegler, Germany. - [68Ga]Ga-FAPI-4 ... were found to be ... (85.5±1.4)% (n=9)
Modular-Lab Standard
Eckert & Ziegler
——97.47 ± 0.26%
decay-corrected
99.18 ± 0.34%FAPI-442705038
2026 Appl Radiat Isot
a commercial fixed tubing (non-cassette) based automated module namely Eckert and Ziegler 'Modular-Lab Standard' (EZ-ML) - decay corrected (dc) radiochemical yield (RCY) and radiochemical purity (RCP) of 97.47 ± 0.26% and 99.18 ± 0.34% respectively

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. 68Ga-FAPI PET/CT for assessing fibroblast activation and disease activity in primary Sjögren's disease: a prospective case-control study.
    2026 · Rheumatology (Oxford) · Prospective
  2. Gastrointestinal cancer with indeterminate 18F-FDG PET/CT findings: Diagnostic efficacy analysis of 68Ga-FAPI-04 PET/MRI.
    2026 · Oncol Lett · Prospective
  3. Triple-tracer PET (18F-FDG, 68Ga-DOTANOC, 68Ga-FAPI) maps inter- and intra-lesional heterogeneity in metastatic high-grade neuroendocrine neoplasms.
    2026 · Sci Rep · Prospective
  4. Radioactive Distribution Patterns of [ 68 Ga]Ga-FAPI-04 in Primary Hepatocellular Carcinoma.
    2026 · Clin Nucl Med · Prospective
  5. 68Ga-FAPI-04 PET for Detecting Occult Peritoneal Metastasis in Locally Advanced Gastric Cancer: Diagnostic Performance and Cost Analyses in a Single-Center, Prospective Cohort Study.
    2026 · J Nucl Med · Prospective
  6. Molecular Imaging of Fibroblast Activation Protein on PET/MRI: Association With Carotid-Ulcerated Plaques and Cerebrovascular Risk Factors.
    2026 · JACC Cardiovasc Imaging · Prospective
  7. Dual targeting PET tracer [68Ga]Ga-PSFA-01 in patients with prostate cancers: A pilot exploratory study.
    2025 · Theranostics · Prospective
  8. Feasibility, Biodistribution, and Preliminary Dosimetry in Peptide-Targeted Radionuclide Therapy of Diverse Adenocarcinomas Using 177Lu-FAP-2286: First-in-Humans Results.
    2022 · J Nucl Med · Prospective
  9. 68Ga-FAPI-04 PET/CT has high diagnostic efficacy in Tg-positive and Tg-negative differentiated thyroid cancer.
    2026 · PLoS One · Retrospective
  10. A pilot study of pretreatment [68Ga]Ga-FAPI-04 PET/CT: correlation of imaging parameters with prognosis and FAP expression in soft tissue sarcoma.
    2026 · Br J Radiol · Retrospective
Show all 42 clinical studies
  1. Prognostic value of multiparameter [68Ga]Ga-DOTA-FAPI-04 PET/MR imaging biomarkers for patients with advanced pancreatic cancer.
    2026 · Eur J Nucl Med Mol Imaging · Retrospective
  2. Correlations between Ki67 expression and uptake of 68Ga-FAPI-04 versus 18F-FDG in different types of tumors: a lesion-based study.
    2025 · Cancer Imaging · Retrospective
  3. Benign and malignant uptake in the postoperative diagnosis of gastrointestinal tumors: a comparative study of 68Ga-FAPI-04 and 18F-FDG.
    2025 · Quant Imaging Med Surg · Retrospective
  4. Comparative Evaluation of 68Ga-FAPI-04 PET for Initial N and M Staging in Gastric Cancer: A Study Against Histopathology and Contrast-Enhanced CT.
    2025 · Clin Nucl Med · Retrospective
  5. Superiority of 68Ga-DOTA-FAPI-04 PET/CT to 18F-FDG PET/CT in the evaluation of different cancers with bone metastases.
    2025 · Bone · Retrospective
  6. Eliminating the second CT scan of dual-tracer total-body PET/CT via deep learning-based image synthesis and registration.
    2025 · Eur J Nucl Med Mol Imaging · Retrospective
  7. Comparative Evaluation of [68Ga]Ga-FAPI-04 PET Versus Conventional Imaging for Peritoneal Carcinomatosis Detection in Ovarian Carcinoma: A Multimodal Imaging Study.
    2026 · J Nucl Med · Clinical study
  8. Superiority of [68Ga]Ga-FAPI-04 Over [18F]-FDG PET/CT and Conventional Imaging in Detecting Peritoneal Carcinomatosis.
    2026 · Ann Surg Oncol · Clinical study
  9. [68Ga]Ga-labeled fibroblast activation protein inhibitor PET/CT for monitoring neoadjuvant chemotherapy responses in breast cancer subtypes.
    2026 · Breast Cancer Res · Clinical study
  10. Negative 68Ga-FAPI-04 Uptake on PET/CT in HNF-1α-mutated Hepatocellular Adenoma: A Distinctive Feature for Differentiating From Hepatocellular Carcinoma.
    2026 · Clin Nucl Med · Clinical study
  11. Comparative 18 F-FDG PET/CT and FAP-targeted PET/CT Findings in Parotid Warthin Tumor.
    2026 · Clin Nucl Med · Clinical study
  12. Time-robust myocardial [68Ga]Ga-FAPI PET biomarker reflects aortic stenosis severity and predicts post-TAVI outcomes.
    2026 · Eur J Nucl Med Mol Imaging · Clinical study
  13. Radiomic features of CECT and SUVmax of dual-tracer PET/CT reveal PD-L1 spatial heterogeneity in PDAC.
    2026 · Cancer Imaging · Clinical study
  14. Hepatic Metastasis From Duodenal Ampullary Carcinoma With Intense FAP Activity But Without FDG Uptake.
    2026 · Clin Nucl Med · Clinical study
  15. Dichotomous Uptake Pattern on [ 18 F]F-FDG and [ 68 Ga]Ga-DOTA-FAPI-04 PET/CT in Lytic, Sclerotic and Marrow Metastatic Skeletal Lesions in Medullary Thyroid Carcinoma.
    2026 · Clin Nucl Med · Clinical study
  16. 68 Ga-FAPI-04 PET/CT Demonstrates Subtype-specific Uptake Patterns in Endometriosis With Added Diagnostic Value Beyond MRI.
    2026 · Clin Nucl Med · Clinical study
  17. Increased 68 Ga-FAPI-04 Uptake in Cerebral Infarction.
    2026 · Clin Nucl Med · Clinical study
  18. Fibroblast activation protein-targeted PET/CT in multiple non-ischemic cardiomyopathies.
    2025 · Eur J Nucl Med Mol Imaging · Clinical study
  19. Pharmacokinetics study of FT-FAPI, a novel multi-nuclide label-able FAP targeting tracer, in mice and healthy volunteers.
    2025 · Eur J Nucl Med Mol Imaging · Clinical study
  20. Physiological Uptake of 68Ga-FAPI-04 in Female Reproductive System.
    2025 · Mol Imaging Biol · Clinical study
  21. Modification of Asp-Peptide Adapters: Giving the FAP-Targeted Radioligand a "Squirrel Tail".
    2025 · J Med Chem · Clinical study
  22. Comparison of [68Ga]Ga-Fibroblast Activation Protein Inhibitor-04 and [18F]FDG PET Imaging for Solitary Fibrous Tumor and Preliminary Application of FAP-Targeted Radiopharmaceutical Therapy.
    2025 · J Nucl Med · Clinical study
  23. 68Ga-FAPI-04 PET/CT Imaging for Assessing Renal Tubulointerstitial Fibrosis in Lupus Nephritis.
    2025 · J Nucl Med · Clinical study
  24. Design, preclinical evaluation, and first-in-human PET study of [68Ga]Ga-PSFA-01: a PSMA/FAP heterobivalent tracer.
    2025 · Eur J Nucl Med Mol Imaging · Clinical study
  25. Seeing Beyond 68GA-DOTANOC and 18F-FDG PET/CT: 68GA-FAPI Only Uptake in a Rare Metastatic Well-differentiated Grade I Pancreatic Neuroendocrine Tumor.
    2026 · Clin Nucl Med · Case report
  26. More Impressive 18 F-FDG PET/CT Findings Than 68 Ga-DOTA-FAPI-04 in a Cervical Chordoma.
    2026 · Clin Nucl Med · Case report
  27. 18 F-FDG Uptake Outperforms 68 Ga-FAPI-04 in Papillary Renal Neoplasm With Reverse Polarity.
    2026 · Clin Nucl Med · Case report
  28. High 68Ga-FAPI-04 and Low 18F-FDG Uptake in a Patient With Hepatic Epithelioid Hemangioendothelioma.
    2026 · Clin Nucl Med · Case report
  29. Intense 68 Ga-FAPI-04 Uptake in a Rare Case of Multifocal Abdominal Wall Endometriosis.
    2026 · Clin Nucl Med · Case report
  30. 18 F-FDG Uptake Outperforms 68 Ga-FAPI in Mediastinal NUT Carcinoma.
    2026 · Clin Nucl Med · Case report
  31. Deficiency of 68 Ga-FAPI-04 PET/CT Compared With 18 F-FDG PET/CT in Staging Metastatic Paraganglioma: A Case Report.
    2025 · Clin Nucl Med · Case report
  32. Focal 68 Ga-FAPI-04 Uptake in Endometriosis at the Rectouterine Pouch.
    2025 · Clin Nucl Med · Case report

Precursor

Common precursor
DOTA-FAPI-04 precursor PMID 35991604 (DOI 10.3389/fchem.2022.939160)
Suppliers seen in the literature
—
Cited suppliers in indexed syntheses
MedChemExpress
Typical final purification
SPE

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Quality control Derived from the published synthesis

Ph. Eur. monograph
not verified No Ph. Eur. check is recorded for this entry.
USP monograph
not verified No USP check is recorded for this entry.
AppearancepHRCP HPLCHPLC UVResidual solvents (GC)Radionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrityMolar activityMetal impuritiesGe-68 breakthrough
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); radiometal tracer -> metal impurities (rule); Ga-68, generator-produced per synthesis data (PMID 35991604) -> Ge-68 breakthrough; receptor ligand with a saturable target -> molar activity (rule); organic solvent confirmed in synthesis data (PMID 35991604) -> GC residual solvents

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

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Notes

Added from reverse module search (stage 6); 9 article(s) with Ga-68.
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