FAPi PET in Pancreatic Ductal Adenocarcinoma (FAP-1)

January 7, 2026 updated by: Ameya Puranik, Tata Memorial Hospital

FAP-1 Study: FAPi PET in Pancreatic Ductal Adenocarcinoma: A Prospective, Exploratory Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Hospital, Mumbai, India
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ameya Puranik, DNB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with biopsy proven pancreatic ductal adenocarcinoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Arm 1: Patients who have been diagnosed with pancreatic ductal adenocarcinoma will undergo Ga-
Patients with pancreatic ductal adenocarcinoma who undergo standard work-up with histopathology and conventional imaging will be referred for Ga-68 FAPi PET/CT
Diagnostic test: Ga-68 FAPi PET/CT
Ga-68 FAPi PET/CT is a whole body scan to assess the FAP receptor expression in patients with pancreatic ductal adenocarcinoma
Other Names:
  • FAPi PET
Study Arm 2: Treated patients with pancreatic ductal adenocarcinoma showing rising tumor markers (CA
Patients who undergo surgery or upfront chemotherapy and subsequently have rising tumor marker levels
Diagnostic test: Ga-68 FAPi PET/CT
Ga-68 FAPi PET/CT is a whole body scan to assess the FAP receptor expression in patients with pancreatic ductal adenocarcinoma
Other Names:
  • FAPi PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging validation of Ga-68 FAPi PET/CT
Time Frame: 6 and 12 months
To calculate sensitivity, specificity, positive predictive value and negative predictive value of quantitative and semi-quantitative parameters on FAPi PET
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Investigators

  • Principal Investigator: Ameya Puranik, DNB, Tata Memorial Hospital, Mumbai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMCIEC4238
  • TRAC/0324/4238/001 (Other Grant/Funding Number: DAE CTC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is against the recommendations of institutional ethics committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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