FAPi PET in Pancreatic Ductal Adenocarcinoma (FAP-1)

Tata Memorial Hospital

Status: Enrolling

Conditions: Adenocarcinoma Pancreas; Pancreatic Cancer

Treatments: Diagnostic Test: Ga-68 FAPi PET/CT

Study type: Observational

Funder types: Other

Identifiers

NCT07342231

TMCIEC4238

TRAC/0324/4238/001 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

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

Treatment:

Diagnostic Test: Ga-68 FAPi PET/CT

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

Treatment:

Diagnostic Test: Ga-68 FAPi PET/CT