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[18F]FAPI-74 PET Imaging for Cancer Detection

Phase 2
Waitlist Available
Led By Esther Mena Gonzalez, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, or pheochromocytoma
Must not have
Uncontrolled intercurrent illness, or medical condition(s) including but not limited to renal failure, liver failure, or psychiatric illness/social situations evaluated by medical history and physical exam that would limit compliance with study requirements and potentially increase risk for the participant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [18f]fapi-74 injection through 3 business days post injection.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new imaging scan called \[18F\]FAPI-74 for detecting certain cancers. The study will compare the effectiveness of this new scan with the current approved tracer

Who is the study for?
This trial is for adults with certain cancers (pancreatic, stomach, liver, bladder, ovarian, bile duct cancer or pheochromocytoma) who are already enrolled in an NIH treatment study. They must be willing to undergo PET scans using a new tracer and an approved tracer.
What is being tested?
[18F]FAPI-74 is a new imaging agent being tested against the standard [18F]FDG for its ability to detect tumors in various cancers. Participants will receive two baseline scans with each tracer and may have repeat scans based on tumor visibility and progression.
What are the potential side effects?
Potential side effects of the tracers used during PET scans can include allergic reactions at the injection site, nausea or vomiting. However, most people tolerate these types of diagnostic tests without significant issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is one of the following types: pancreatic, bile duct, liver, stomach, bladder, ovarian, or pheochromocytoma.
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I can perform daily activities with minimal assistance.
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I am breastfeeding but can stop for 2 months after each study scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any severe illnesses that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-treatment and recurrence
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-treatment and recurrence for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean number of lesions
Secondary study objectives
Safety of [18F]FAPI 74 PET imaging
Standardized uptake value

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: 1/Arm 1Experimental Treatment2 Interventions
\[18F\]FAPI-74 and 18F-FDG PET imaging
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[18F]FDG
2014
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,925 Previous Clinical Trials
41,017,695 Total Patients Enrolled
24 Trials studying Pheochromocytoma
36,887 Patients Enrolled for Pheochromocytoma
Esther Mena Gonzalez, M.D.Principal InvestigatorNational Cancer Institute (NCI)
~213 spots leftby Jun 2028
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