Clinical trial · Observational
FAPi PET in Pancreatic Ductal Adenocarcinoma
FAP-1 Study: FAPi PET in Pancreatic Ductal Adenocarcinoma: A Prospective, Exploratory Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pancreatic adenocarcinoma commonly referred to as pancreatic cancer is a cancer which is known to involve the pancreas and the surrounding structures like blood vessels, which makes it an aggressive cancer. Treatment of the cancer is decided by how much the disease has spread. It has been understood from recent studies that there are some components of the tumor which are not detected by standard CT scan. The tissue in the tumor microenvironment leads to further spread of tumor. The tissue which is seen near the tumor has many attachments on the surface which are currently being studied. One of the most common attachments is Fibroblast activation protein (FAP), which is seen on the surface of tumor tissue. A radioactive tracer Gallium-68 is attached to a small protein known as 'peptide' named 'FAP inhibitor (FAPi)' which shall bind to FAP. Then a PET scan will be performed which shall help in understanding how much of the tissue is seen on the scan in addition to the pancreatic tumor. The investigators shall assess whether the radiotracer (Gallium-68 labeled FAPi) binds to other sites like liver or other organs where the cancer is likely to spread. From the study, the investigators shall study whether the new scanning technique is beneficial as compared to the standard CT scanning. Hence, the investigators would perform Gallium-68-labeled FAPi PET scan in addition to the standard CT scan and compare the results.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma Pancreas | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga-68 FAPi PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Study Arm 1: Patients who have been diagnosed with pancreatic ductal adenocarcinoma will undergo Ga-
- description
- Patients with pancreatic ductal adenocarcinoma who undergo standard work-up with histopathology and conventional imaging will be referred for Ga-68 FAPi PET/CT
- interventionNames
- Diagnostic Test: Ga-68 FAPi PET/CT
- label
- Study Arm 2: Treated patients with pancreatic ductal adenocarcinoma showing rising tumor markers (CA
- description
- Patients who undergo surgery or upfront chemotherapy and subsequently have rising tumor marker levels
- interventionNames
- Diagnostic Test: Ga-68 FAPi PET/CT
Primary outcomes (1)
- measure
- Imaging validation of Ga-68 FAPi PET/CT
- timeFrame
- 6 and 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any gender with age more than 18 years * Patients with biopsy-proven pancreatic ductal adenocarcinoma * Patient willing to participate in study Exclusion Criteria: * Patient with concurrent malignancy * Pregnancy and lactation
References
Publications (1)
- BACKGROUNDYuan H, Liu E, Zhang G, Lai C, Zhang Q, Shang Y, Cheng Z, Jiang L. Diagnostic efficacy of [68Ga]Ga-DOTA-GPFAPI-04 in patients with solid tumors in a head-to-head comparison with [18F]F-FDG: results from a prospective clinical study. Eur J Nucl Med Mol Imaging. 2024 Sep;51(11):3360-3372. doi: 10.1007/s00259-024-06756-0. Epub 2024 May 10. PMID 38727829