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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults > 18 years (yrs.) with treatment-naive biopsy-proven PDA or with findings diagnostic for PDA on baseline imaging (CT, MRI, or PET)

Localized disease expected to undergo surgical resection following neoadjuvant therapy (NAT)

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Ability to provide informed consent

Disqualifiers

Hypersensitivity to any excipients in 68Ga-FAPI-46

Require emergency surgery

Non-PDA histology on biopsy

Histopathologically proven metastatic PDA

Trial design

Design model

Single group

Treatments tested in this trial

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Gallium Ga 68 FAPi-46

    Drug

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: Diagnostic (gallium GA 68 FAPi-46, PET/CT)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Diagnostic performance of fibroblast-activation-protein-inhibitors (FAPI) positron emission tomography (PET) for detection and quantification of cancer-associated fibroblasts (CAFs) in pancreatic ductal adenocarcinoma (PDA)

Using surgical immunohistochemistry (IHC) as gold standard.

Time frame
Up to 5 years
2

Relationship between 68Ga-FAPI-46 PET metrics in PDA

Relationship between 68Ga-FAPI-46 PET metrics assessed

Time frame
Up to 5 years
3

Relationship between 68Ga-FAPI-46 PET metrics and cancer antigen 19-9 (CA19-9) biomarkers in PDA

Relationship between 68Ga-FAPI-46 PET metrics and cancer antigen 19-9 (CA19-9) being assessed.

Time frame
Up to 5 years
4

Relationship between 68Ga-FAPI-46 PET metrics and Kirsten rat sarcoma (KRAS), circulating tumor deoxyribonucleic acid (ctDNA) biomarkers in PDA

Relationship between 68Ga-FAPI-46 PET metrics and Kirsten rat sarcoma (KRAS), circulating tumor deoxyribonucleic acid (ctDNA) being assessed.

Time frame
Up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator