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FAPI-74 PET Scan for Gastrointestinal Cancer (18F-FAPI-74 GI Trial)
Phase 2
Recruiting
Research Sponsored by SOFIE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will measure how well a PET scan can detect cells expressing a gene linked to GI cancers, compared to standard methods.
Who is the study for?
Adults with confirmed gastrointestinal cancers (like pancreatic, liver, colorectal, stomach, or bile duct cancer) who have a tissue sample from a biopsy and haven't had treatment since the biopsy can join. They must not be pregnant or breastfeeding without agreeing to discard breast milk for 24 hours post-injection.
What is being tested?
[18F]FAPI-74 PET/CT scans are being tested to see if they're effective in detecting FAP expressing cells in patients with various GI cancers. The results will be compared to standard imaging and tissue analysis.
What are the potential side effects?
Potential side effects may include reactions related to the injection of [18F]FAPI-74 such as irritation at the injection site or allergic reactions due to its components like sodium acetate or ethanol.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.
Secondary study objectives
Further characterize the safety profile of [18F]FAPI-74 in subjects utilizing Common Terminology Criteria for Adverse Events (CTCAE v5)
Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for histopathology.
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: [18F]FAPI-74 PET/CTExperimental Treatment1 Intervention
Patients receive \[18F\]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later
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Who is running the clinical trial?
SOFIELead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any treatments between my tissue sample and PET scan.I have been diagnosed with a type of gastrointestinal cancer.I do not have any infections that need strong medication which could affect my treatment.My liver or kidney function is not normal.I need urgent surgery that cannot be postponed for a study.I am 18 years old or older.I have a tissue sample from a biopsy or will have one taken.I am allergic to certain chemicals used in [18F]FAPI-74.
Research Study Groups:
This trial has the following groups:- Group 1: [18F]FAPI-74 PET/CT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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