RecruitingPhase 2NCT05518903

Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma

Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA)


Sponsor

Mayo Clinic

Enrollment

130 participants

Start Date

Nov 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts (CAFs) in patients with pancreatic ductal adenocarcinoma (PDA) that has not spread to other parts of the body (localized). CAFs are a type of connective tissue cell that are found within or near cancerous tissue. Many CAFs express a protein called fibroblast activation protein (FAP) that are not found on healthy cells in large amounts. 68Ga-FAPI-46 is a radioactive chemical compound designed to circulate through the body and attach itself to FAP on PDA cells. A PET/CT scan is then used to detect the location of FAP lesions. PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional (3-D) views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Giving 68Ga-FAPI-46 PET/CT may help doctors improve upon the diagnosis and management of PDA.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a new type of PET scan (using a tracer called 68Ga-FAPI-46) to get better images of pancreatic cancer (specifically pancreatic ductal adenocarcinoma, or PDA) before and after pre-surgery treatment, to see if these scans can predict how well patients respond to treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with pancreatic cancer (PDA), either by biopsy or imaging - Your cancer is localized (not widely spread) and you are expected to have surgery after pre-surgery chemotherapy - Your overall health is good enough for treatment (ECOG 0–2) - You are able to give informed consent **You may NOT be eligible if...** - Your cancer has spread to other organs (metastatic disease confirmed by biopsy) - You are allergic to the scan tracer (68Ga-FAPI-46) - You need emergency surgery - You are pregnant or breastfeeding - Your cancer type is not PDA Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREComputed Tomography

Undergo CT

DRUGGallium Ga 68 FAPi-46

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT05518903


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