Imaging test with 68Ga-FAPI-46 scan for pancreatic cancer staging

Trial details

Who runs it

Centre Hospitalier Universitaire Vaudois

Trial code

NCT06911021

Record updated

4 April 2025

Original description

This clinical study investigates the use of a new imaging technique called 68Ga-FAPI-46 PET/CT in people with pancreatic ductal adenocarcinoma (PDAC), a type of cancer known for its rapid progression, late diagnosis, and poor survival rate. One of the main challenges with pancreatic cancer is that standard images like MRI and CT, while helpful, are not always able to clearly show how far the cancer has spread or where exactly the tumor ends. This can make surgery and treatment planning more difficult and less precise.Read full original descriptionShow less

68Ga-FAPI-46 PET/CT for Tumor Fibroblast Imaging to Refine Tumor Assessment and Therapeutic Strategies of Pancreatic Adenocarcinoma

This clinical study investigates the use of a new imaging technique called 68Ga-FAPI-46 PET/CT in people with pancreatic ductal adenocarcinoma (PDAC), a type of cancer known for its rapid progression, late diagnosis, and poor survival rate. One of the main challenges with pancreatic cancer is that standard images like MRI and CT, while helpful, are not always able to clearly show how far the cancer has spread or where exactly the tumor ends. This can make surgery and treatment planning more difficult and less precise.

The new image technique being studied, 68Ga-FAPI-46 PET/CT, works by injecting a small and safe amount of a radioactive substance into a vein. This substance travels through the body and attaches to a specific protein called FAP, which is found in large amounts in the tissue that surrounds many pancreatic tumors. By sticking to this protein, the tracer highlights not only the tumor but also the surrounding area that may be affected by the cancer. This results in very detailed images that may show the tumor more clearly than other techniques.

Each participant in the study will receive a single injection of the tracer, and about an hour later they will have the PET/CT scan. The scan itself is quick, painless, and non-invasive, and takes about 20 minutes. A few days later, participants will receive a follow-up phone call to check if they experienced any side effects, though previous studies with over 1,000 people have shown the tracer to be very safe.

The purpose of the study is to find out whether this new technique provides more useful and accurate information than the standard images currently used. It may help better detect the size of the tumor, see if it has spread to other parts of the body, and give doctors a clearer idea of how to plan surgery. This could make it easier to remove the tumor completely and choose the most effective treatment for each patient.

This pilot study is being conducted at Lausanne University Hospital (CHUV) with 20 adult participants over two years. CHUV is the first hospital in Switzerland to offer this kind of scan. If the study is successful, this scan may become a regular part of care for people with pancreatic cancer and could also be used in other cancers in the future.

Inclusion: Age ≥18 years; Karnofsky index ≥80%; Operable or operable borderline tumor after neoadjuvant chemotherapy response; Planned surgical tumor resection; SOC imaging (ceCT and MRI) performed as pre-surgery exams; Signed informed consent.

Exclusion: Severe renal insufficiency (GFR<30 mL/min/1.73m²); Bilirubin >3× the upper limit; Hemoglobin <8 g/dL; Absolute neutrophil count <1000/mm³; Platelets <75,000/µL; Pregnancy or breastfeeding; Claustrophobia; Liver enzymes (ALAT, ASAT >5× the upper limit); Inability to give informed consent or follow study procedures; The patient refuses to receive information regarding incidental findings.

ClinicalTrials.gov NCT06911021