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

NCT ID: NCT05518903

Condition: 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

Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
FAPI-46

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Computed Tomography
Description: Undergo CT
Arm group label: Diagnostic (gallium GA 68 FAPi-46, PET/CT)

Other name: CAT

Other name: CAT Scan

Other name: Computed Axial Tomography

Other name: Computerized Axial Tomography

Other name: Computerized axial tomography (procedure)

Other name: Computerized Tomography

Other name: CT

Other name: CT Scan

Other name: tomography

Intervention type: Drug
Intervention name: Gallium Ga 68 FAPi-46
Description: Given IV
Arm group label: Diagnostic (gallium GA 68 FAPi-46, PET/CT)

Other name: 68Ga-FAPi-46

Other name: Gallium-68-FAPi-46

Intervention type: Procedure
Intervention name: Positron Emission Tomography
Description: Undergo PET
Arm group label: Diagnostic (gallium GA 68 FAPi-46, PET/CT)

Other name: Medical Imaging, Positron Emission Tomography

Other name: PET

Other name: PET Scan

Other name: Positron emission tomography (procedure)

Other name: Positron Emission Tomography Scan

Other name: Positron-Emission Tomography

Other name: proton magnetic resonance spectroscopic imaging

Other name: PT

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic in Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015
Email: mayocliniccancerstudies@mayo.edu

Investigator:
Last name: Ajit H. Goenka, M.D.
Email: Principal Investigator

Start date: November 15, 2022

Completion date: June 30, 2028

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05518903
https://www.mayo.edu/research/clinical-trials

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