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68Ga-FAPI-46 PET/CT Scan for Pancreatic Cancer

Phase 2

Recruiting

Led By Ajit H Goenka

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Histopathologically proven metastatic PDA

Require emergency surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether a 68Ga-FAPI-46 PET/CT scan can image cancer-associated fibroblasts in patients with localized pancreatic ductal adenocarcinoma.

Who is the study for?

This trial is for adults over 18 with localized pancreatic ductal adenocarcinoma (PDA) who haven't started treatment yet. They should be fit enough for surgery after initial therapy and have an ECOG performance status of 0-2, meaning they can care for themselves. Pregnant women, those allergic to ingredients in the scan compound, or patients needing emergency surgery cannot participate.

What is being tested?

The trial is testing a new type of PET/CT scan using a radioactive compound called 68Ga-FAPI-46 that targets cancer-associated fibroblasts in PDA. The goal is to see if this method improves diagnosis and management by providing clearer images of where the cancer cells are located.

What are the potential side effects?

Potential side effects may include reactions related to the injection of the radioactive substance such as mild pain or redness at the injection site. Allergic reactions could occur but are rare since individuals with known hypersensitivity are excluded.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and have a confirmed diagnosis of pancreatic ductal adenocarcinoma (PDA).

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My cancer is localized and planned for surgery after initial treatment.

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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is confirmed to be metastatic pancreatic ductal adenocarcinoma.

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I need emergency surgery.

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I am not allergic to any components in 68Ga-FAPI-46.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

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 cancer antigen 19-9 (CA19-9) biomarkers in PDA

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (gallium GA 68 FAPi-46, PET/CT)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Positron Emission Tomography

2011

Completed Phase 2

~2200