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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
18F-FAPI-74 GI Trial 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.Check my eligibility
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.See study design
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.
18F-FAPI-74 GI Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.
Secondary outcome measures
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.
18F-FAPI-74 GI 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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the [18F]FAPI-74 PET/CT diagnostic tool been given clearance by the FDA?
"Our experts at Power have rated the safety of [18F]FAPI-74 PET/CT a 2, as this is currently undergoing Phase 2 trials with evidence supporting its security but none to back up its effectiveness."
Answered by AI
What is the current participant count of this clinical investigation?
"Yes, the clinicaltrials.gov website confirms that this medical study is actively recruiting participants and has been since April 28th 2023. The last update was on May 11th 2023. A total of 120 patients will be accepted from one location."
Answered by AI
Are there any opportunities to participate in this experiment at present?
"That is accurate. According to the clinical trial registry, this experiment, which was initially announced on April 28th 2023, is presently enlisting participants. The survey requires 120 persons at 1 centre."
Answered by AI
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