Diagnostic (gallium GA 68 FAPi-46, PET/CT) for Stage I Pancreatic Cancer AJCC v8

Phase-Based Progress Estimates
Mayo Clinic in Rochester, Rochester, MN
Stage I Pancreatic Cancer AJCC v8+6 More
Positron Emission Tomography - Procedure
All Sexes
What conditions do you have?

Study 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 localized (has not spread to other parts of the body) pancreatic ductal adenocarcinoma (PDA). 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. 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 scans help to measure the information about functions of tissues and organs within the body. CT scans use X-rays to create images of the bones and internal organs within the body. Giving 68Ga-FAPI-46 PET/CT may help doctors improve upon the diagnosis and management of PDA.

Eligible Conditions

  • Stage I Pancreatic Cancer AJCC v8
  • Stage 0 Pancreatic Cancer AJCC v8
  • Resectable Pancreatic Ductal Adenocarcinoma (PDAC)
  • Stage IIA Pancreatic Cancer AJCC v8
  • Localized Pancreatic Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Up to 5 years

Up to 5 years
Correlation between 68Ga-FAPI-46 PET metrics in PDA
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)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Diagnostic (gallium GA 68 FAPi-46, PET/CT)
1 of 1
Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: Diagnostic (gallium GA 68 FAPi-46, PET/CT) · No Placebo Group · Phase 2

Diagnostic (gallium GA 68 FAPi-46, PET/CT)Experimental Group · 3 Interventions: Positron Emission Tomography, Gallium Ga 68 FAPi-46, Computed Tomography · Intervention Types: Procedure, Drug, Procedure
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
Completed Phase 2
Computed Tomography
Completed Phase 2

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Closest Location: Mayo Clinic in Rochester · Rochester, MN
Photo of Rochester  1Photo of Rochester  2Photo of Rochester  3
2021First Recorded Clinical Trial
2 TrialsResearching Stage I Pancreatic Cancer AJCC v8
502 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a localized disease that is expected to undergo surgical resection following neoadjuvant therapy (NAT).
You have a performance status of 0-2.
You are able to provide informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.