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

Stage IIA Pancreatic Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518903
• Other study ID #: MC220903
• Secondary ID: NCI-2022-0680622
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2022
• Est. completion date: June 30, 2028

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES: I. To determine the sensitivity and specificity of gallium Ga 68 FAPi-46 (68Ga-FAPI-46) PET for detection and quantification of cancer-associated fibroblasts (CAFs) in pancreatic ductal adenocarcinoma (PDA). II. Construct, test and validate a model of surgical benefit or futility in potentially resectable PDA using 68Ga-FAPI-46 PET biomarkers in combination with other biomarkers of disease. OUTLINE: Patients receive 68Ga-FAP-46 intravenously (IV), then allow 60 minutes for 68Ga-FAPI-46 uptake. Patients then undergo PET/CT scans over 30 minutes at baseline (before standard of care [SOC] therapy), up to 2 scans approximately 8 weeks apart (at SOC re-staging visits), and a then a scan within 4 weeks of SOC surgical resection, if applicable. After completion of study treatment, patients are followed up for 5 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Hypersensitivity to any excipients in 68Ga-FAPI-46
• Require emergency surgery
• Non-PDA histology on biopsy
• Histopathologically proven metastatic PDA
• Pregnant or lactating women

Related Conditions & MeSH terms

• Adenocarcinoma
• Localized Pancreatic Adenocarcinoma
• Pancreatic Neoplasms
• Resectable Pancreatic Ductal Adenocarcinoma
• Stage 0 Pancreatic Cancer AJCC v8
• Stage I Pancreatic Cancer AJCC v8
• Stage IIA Pancreatic Cancer AJCC v8

Intervention

Procedure:
• Computed Tomography
Undergo CT

Drug:
• Gallium Ga 68 FAPi-46
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years
Primary	Relationship between 68Ga-FAPI-46 PET metrics in PDA	Relationship between 68Ga-FAPI-46 PET metrics assessed	Up to 5 years
Primary	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.	Up to 5 years
Primary	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.	Up to 5 years
Primary	Relationship between 68Ga-FAPI-46 PET metrics and staging examinations in PDA	Relationship between 68Ga-FAPI-46 PET metrics and fludeoxyglucose F-18 (FDG) PET staging exam being assessed.	Up to 5 years
Primary	Relationship between 68Ga-FAPI-46 PET metrics and staging examinations in PDA	Relationship between 68Ga-FAPI-46 PET metrics and magnetic resonance imaging (MRI) staging exam being assessed.	Up to 5 years

External Links

•   Mayo Clinic Clinical Trials