To hear about similar clinical trials, please enter your email below
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