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

Phase 2

Recruiting

Led By Ajit H. Goenka, M.D.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,511 Total Patients Enrolled

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,010 Total Patients Enrolled

Ajit H. Goenka, M.D.Principal InvestigatorMayo Clinic in Rochester

2 Previous Clinical Trials

102 Total Patients Enrolled

Media Library

Gallium Ga 68 FAPi-46 Clinical Trial Eligibility Overview. Trial Name: NCT05518903 — Phase 2

Pancreatic Cancer Research Study Groups: Diagnostic (gallium GA 68 FAPi-46, PET/CT)

Pancreatic Cancer Clinical Trial 2023: Gallium Ga 68 FAPi-46 Highlights & Side Effects. Trial Name: NCT05518903 — Phase 2

Gallium Ga 68 FAPi-46 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518903 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being enrolled in this research project at this time?

"Unfortunately, this particular trial is not presently enrolling patients. The listing on clinicaltrials.gov says that the study was last updated on 8/26/2022 and it appears as if recruitment has closed. However, there are 1285 other trials that are still recruiting patients."

Answered by AI

Do people experience any serious side effects from Gallium Ga 68 FAPi-46?

"Gallium Ga 68 FAPi-46 is a Phase 2 medication, meaning that while there is some data affirming its safety, none of the clinical trials done thus far have been effective."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "An Investigational Scan (68Ga-FAPI-46 PET/CT) for the Imaging of Cancer-Associated Fibroblasts in Patients With Localized Pancreatic Ductal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05518903.