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[18F]3F4AP Imaging for Brain Conditions

Phase 1
Waitlist Available
Led By Georges El Fakhri, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Any woman of childbearing potential, who is seeking to become pregnant, is breastfeeding, or who suspects she may be pregnant will not be enrolled in the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety of a new imaging agent, [18F]3F4AP, in people with brain injuries, Alzheimer's Disease, and other forms of cognitive impairment. The goal is to see if this agent can help doctors better understand and treat these conditions.

Who is the study for?
This trial is for adults over 18, except those with Alzheimer's who should be aged 60-90. It's not suitable for pregnant or breastfeeding women, anyone trying to get pregnant, or individuals ineligible for PET/CT or MRI studies.
What is being tested?
[18F]3F4AP is being tested to see if it can help image brain conditions like traumatic brain injury and neurodegenerative diseases. The study will check its safety, radiation doses in organs, how the body processes it, and compare imaging results with neuropsychological tests.
What are the potential side effects?
Potential side effects are expected to be minimal but may include changes in vitals as a reaction to [18F]3F4AP. Safety assessments will monitor any adverse events following administration.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, trying to get pregnant, or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Traumatic Brain InjuryExperimental Treatment1 Intervention
Group II: Safety/Dosimetry CohortExperimental Treatment1 Intervention
Group III: AD/MCIExperimental Treatment1 Intervention
Group IV: Healthy ControlsActive Control1 Intervention

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,317,941 Total Patients Enrolled
Georges El Fakhri, PhD1.01 ReviewsPrincipal Investigator - Mass. General Hospital
Massachusetts General Hospital
Marc Normandin, PhDPrincipal InvestigatorMass. General Hospital

Media Library

F18-3F4AP Clinical Trial Eligibility Overview. Trial Name: NCT04710550 — Phase 1
Alzheimer's Disease Research Study Groups: Healthy Controls, Safety/Dosimetry Cohort, Traumatic Brain Injury, AD/MCI
Alzheimer's Disease Clinical Trial 2023: F18-3F4AP Highlights & Side Effects. Trial Name: NCT04710550 — Phase 1
F18-3F4AP 2023 Treatment Timeline for Medical Study. Trial Name: NCT04710550 — Phase 1
~2 spots leftby Dec 2025
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