FAPi PET in Pancreatic Ductal Adenocarcinoma

NCT07342231 | Recruiting DMC

• 2 other identifiers: TMCIEC4238TRAC/0324/4238/001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Cancer; Adenocarcinoma Pancreas

Keywords

Fibroblast activation protein; PETCT; FAPi

Outcome Measures

Primary Outcomes (1)

• Imaging validation of Ga-68 FAPi PET/CT

  To calculate sensitivity, specificity, positive predictive value and negative predictive value of quantitative and semi-quantitative parameters on FAPi PET

  6 and 12 months

Study Arms (2)

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

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

Interventions

Ga-68 FAPi PET/CT DIAGNOSTIC_TEST

Ga-68 FAPi PET/CT is a whole body scan to assess the FAP receptor expression in patients with pancreatic ductal adenocarcinoma

Also known as: FAPi PET

Study Arm 1: Patients who have been diagnosed with pancreatic ductal adenocarcinoma will undergo Ga-; Study Arm 2: Treated patients with pancreatic ductal adenocarcinoma showing rising tumor markers (CA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with biopsy proven pancreatic ductal adenocarcinoma

You may qualify if:

• Any gender with age more than 18 years
• Patients with biopsy-proven pancreatic ductal adenocarcinoma
• Patient willing to participate in study

You may not qualify if:

• Patient with concurrent malignancy
• Pregnancy and lactation

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital, Mumbai, India

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (1)

• Yuan 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 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Ameya Puranik, DNB

  Tata Memorial Hospital, Mumbai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sushil Yadav, MSc

CONTACT

912224177000; sushilyadav.crc@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 15, 2026
• Study Start: January 4, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)