Recruiting
Phase 2

68Ga-FAPI-46

Sponsor:

Mayo Clinic

Code:

NCT05518903

Conditions

Localized Pancreatic Adenocarcinoma

Resectable Pancreatic Ductal Adenocarcinoma

Stage 0 Pancreatic Cancer AJCC v8

Stage I Pancreatic Cancer AJCC v8

Stage IIA Pancreatic Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Gallium Ga 68 FAPi-46

Positron Emission Tomography

Study Details

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.

Conditions

Localized Pancreatic Adenocarcinoma

Resectable Pancreatic Ductal Adenocarcinoma

Stage 0 Pancreatic Cancer AJCC v8

Stage I Pancreatic Cancer AJCC v8

Stage IIA Pancreatic Cancer AJCC v8

Study ID

NCT05518903

Start date

Nov 15, 2022

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

130 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (gallium GA 68 FAPi-46, PET/CT)

Patients 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

Computed Tomography

Undergo CT

Gallium Ga 68 FAPi-46

Given IV

Positron Emission Tomography

Undergo PET

Primary outcome measure

  • 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) [ Time Frame: Up to 5 years ]
  • Relationship between 68Ga-FAPI-46 PET metrics in PDA [ Time Frame: Up to 5 years ]
  • Relationship between 68Ga-FAPI-46 PET metrics and cancer antigen 19-9 (CA19-9) biomarkers in PDA [ Time Frame: Up to 5 years ]
  • Relationship between 68Ga-FAPI-46 PET metrics and Kirsten rat sarcoma (KRAS), circulating tumor deoxyribonucleic acid (ctDNA) biomarkers in PDA [ Time Frame: Up to 5 years ]
  • Relationship between 68Ga-FAPI-46 PET metrics and staging examinations in PDA [ Time Frame: Up to 5 years ]
  • Relationship between 68Ga-FAPI-46 PET metrics and staging examinations in PDA [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Ajit H. Goenka, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-10.