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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Any gender with age more than 18 years

• Patients with biopsy-proven pancreatic ductal adenocarcinoma

• Patient willing to participate in study

Locations
Other Locations
India
Tata Memorial Hospital, Mumbai, India
RECRUITING
Mumbai
Contact Information
Primary
Sushil Yadav, MSc
sushilyadav.crc@gmail.com
912224177000
Time Frame
Start Date: 2025-01-04
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 60
Treatments
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
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
Sponsors
Leads: Tata Memorial Hospital

This content was sourced from clinicaltrials.gov