6 active not recruiting, 4 recruiting, 2 completed, 1 terminated. 6 Phase 2, 4 Early Phase 1, 4 Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Recruiting 3, Completed 2, Terminated 1 |
| Early Phase 1 | 4 | Active not recruiting 3, Withdrawn 1 |
| Phase 1 | 4 | Active not recruiting 3, Recruiting 1 |
| Not applicable | 1 | Unknown 1 |
Follow FAPI-46: new trials by email Literature Review of FAPI-46 trials Research Report on FAPI-46
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pilot Study Evaluating Tumor Microenvironment Interaction in Solid Tumor Patients 68Ga-FAPI-46 - Solid Tumor Cancer, Solid Tumor Malignancy | Early Phase 1 | Withdrawn | Eben Rosenthal | 2027-01-01 | 2026-01-21 | |
| Multimodal Imaging With FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer [68Ga]Ga-FAPI-46 - Carcinoma, Intraductal, Noninfiltrating | Phase 2 | Recruiting | Universität Münster | 30 | 2026-02-20 | 2026-06-03 |
| Cutting Edge Imaging With PET-FAPI for Earlier Pancreatic Cancer Diagnosis (INDIGO-FAPI) 68Ga-FAPI-46 for PET / CT scan - Pancreatic Ductal Adenocarcinoma (PDAC) | Phase 2 | Recruiting | Institut Curie | 35 | 2025-12-02 | 2026-04-15 |
| Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers Computed Tomography, Fludeoxyglucose F-18, Gallium Ga 68 FAPi-46 - Anal Carcinoma, Bladder Carcinoma | Phase 1 | Active not recruiting | Jonsson Comprehensive Cancer Center | 30 | 2025-08-01 | 2026-10-20 |
| [68Ga]Ga-FAPI PET/CT in Gastric and Gastroesophageal Junctional Cancer 68Ga-FAPi-46 - Gastric Cancer, Gastro Esophageal Junctional Cancer | Phase 2 | Completed | Aalborg University Hospital | 20 | 2024-02-15 | 2025-12-30 |
| [68Ga]Ga-FAPI-46 PET/CT in Ovarian Cancer 68Ga-FAPi-46 - Ovarian Cancer | Phase 2 | Terminated | Aalborg University Hospital | 20 | 2023-11-17 | 2026-05-27 |
| Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma Computed Tomography, Gallium Ga 68 FAPi-46, Positron Emission Tomography - Localized Pancreatic Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma | Phase 2 | Recruiting | Mayo Clinic | 130 | 2022-11-15 | 2026-08-10 |
| Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma [68Ga]FAPI-46 - PDAC - Pancreatic Ductal Adenocarcinoma, FAP | Phase 2 | Completed | SOFIE | 63 | 2022-05-02 | 2026-05-29 |
| FAPI-CUP- Evaluating FAPI as a Novel Radiopharmaceutical for Cancer of Unknown Primary 68Ga-FAPi-46, PET/CT imaging - Cancer of Unknown Primary Site | Not applicable | Unknown | Peter MacCallum Cancer Centre, Australia | 150 | 2022-02-23 | 2023-03-31 |
| FAPI PET for Lung Fibrosis 68Ga-FAPi-46, Computed Tomography, Positron Emission Tomography - Interstitial Lung Disease, Idiopathic Interstitial Pneumonias | Early Phase 1 | Active not recruiting | University of California, Los Angeles | 30 | 2021-11-16 | 2026-08-20 |
| PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI 68Ga-FAPI-46, PET/CT - Pancreatic Neoplasms, Stomach Neoplasms | Phase 1 | Recruiting | Karolinska University Hospital | 410 | 2021-06-02 | 2021-12-29 |
| Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation Computed Tomography, Gallium Ga 68 FAPi-46, Positron Emission Tomography - Metastatic Malignant Neoplasm in the Prostate Gland, Prostate Carcinoma | Phase 1 | Active not recruiting | Jonsson Comprehensive Cancer Center | 30 | 2020-09-09 | 2026-08-20 |
| 68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma Computed Tomography, Gallium Ga 68 FAPi-46, Positron Emission Tomography - Metastatic Sarcoma, Recurrent Sarcoma | Early Phase 1 | Active not recruiting | Jonsson Comprehensive Cancer Center | 18 | 2020-09-08 | 2026-09-17 |
| Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers Computed Tomography, Gallium Ga 68 FAPi-46, Positron Emission Tomography - Bladder Carcinoma, Cervical Carcinoma | Phase 1 | Active not recruiting | Jonsson Comprehensive Cancer Center | 26 | 2020-08-27 | 2026-02-05 |
| Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues Computed Tomography, Gallium Ga 68 FAPi-46, Gallium Ga 68-labeled PSMA-11 - Breast Carcinoma, Colon Carcinoma | Early Phase 1 | Active not recruiting | Jonsson Comprehensive Cancer Center | 29 | 2019-11-05 | 2026-08-21 |
Pancreatic Neoplasms (4) · Stomach Neoplasms (4) · Breast Neoplasms (3) · Neoplasms (3) · Ovarian Neoplasms (3) · Adrenal Gland Neoplasms (2) · Brain Neoplasms (2) · Carcinoma, Hepatocellular (2) · Carcinoma, Transitional Cell (2) · Cholangiocarcinoma (2) · Esophageal Neoplasms (2) · Lung Neoplasms (2) · Neoplasms, Unknown Primary (2) · Neuroendocrine Tumors (2) · Prostatic Neoplasms (2)
Jonsson Comprehensive Cancer Center (5) · Aalborg University Hospital (2) · Eben Rosenthal (1) · Institut Curie (1) · Karolinska University Hospital (1) · Mayo Clinic (1) · Peter MacCallum Cancer Centre, Australia (1) · SOFIE (1) · University of California, Los Angeles (1) · Universität Münster (1)
United States (9) · Denmark (2) · Australia (1) · France (1) · Germany (1) · Sweden (1)
Jeremie Calais (3) · Jeremie Calais, MD (3) · Ajit H. Goenka, M.D. (1) · Eben Rosenthal, MD (1) · Nicolas Deleval (1) · Philipp Backhaus, Dr. med. (1) · Rimma Axelsson, Professor (1)
PMID 36512649, PMID 38011131, PMID 38849741, PMID 39362770, PMID 41101974, PMID 42086826
2023 (2), R01CA272628 (1)