FAPi PET in Pancreatic Ductal Adenocarcinoma

NCT ID: NCT07342231

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-04

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Cancer Adenocarcinoma Pancreas

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Ga-68 FAPi PET/CT

Intervention Type DIAGNOSTIC_TEST

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

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

Ga-68 FAPi PET/CT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FAPi PET

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tata Memorial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ameya Puranik

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ameya Puranik, DNB

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Hospital, Mumbai

Locations

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Tata Memorial Hospital, Mumbai, India

Mumbai, Maharashtra, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Sushil Yadav, MSc

Role: CONTACT

912224177000 ext. 7019

Facility Contacts

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Sushil Yadav

Role: primary

912224177000 ext. 7019

Farkhanda Khan, MSc

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 38727829 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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TRAC/0324/4238/001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TMCIEC4238

Identifier Type: -

Identifier Source: org_study_id

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