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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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 Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Gallium Ga 68 FAPi-46

Intervention Type DRUG

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET

Interventions

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Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Gallium Ga 68 FAPi-46

Given IV

Intervention Type DRUG

Positron Emission Tomography

Undergo PET

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography CT CT Scan tomography 68Ga-FAPi-46 Gallium-68-FAPi-46 Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging PT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No