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)
4 other identifiers
interventional
130
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
August 29, 2022
CompletedStudy Start
First participant enrolled
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
October 2, 2025
September 1, 2025
4.6 years
August 24, 2022
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (6)
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
Relationship between 68Ga-FAPI-46 PET metrics in PDA
Relationship between 68Ga-FAPI-46 PET metrics assessed
Up to 5 years
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
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
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
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
Study Arms (1)
Diagnostic (gallium GA 68 FAPi-46, PET/CT)
EXPERIMENTALPatients receive 68Ga-FAP-46 IV, then allow 60 minutes for 68Ga-FAPI-46 uptake. Patients then undergo PET/CT scans over 30 minutes at baseline (before 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.
Interventions
Undergo CT
Given IV
Undergo PET
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hypersensitivity to any excipients in 68Ga-FAPI-46
- Require emergency surgery
- Non-PDA histology on biopsy
- Histopathologically proven metastatic PDA
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ajit H. Goenka, M.D.
Mayo Clinic in Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 29, 2022
Study Start
November 15, 2022
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
October 2, 2025
Record last verified: 2025-09