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[18F]3F4AP Imaging for Brain Conditions

Phase 1

Waitlist Available

Led By Marc Normandin, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

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

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,473 Total Patients Enrolled

Marc Normandin, PhDPrincipal InvestigatorMass. General Hospital

Georges El Fakhri, PhD1.01 ReviewsPrincipal Investigator - Mass. General Hospital

Massachusetts General Hospital

Media Library

F18-3F4AP Clinical Trial Eligibility Overview. Trial Name: NCT04710550 — Phase 1

Traumatic Brain Injury Research Study Groups: Healthy Controls, Safety/Dosimetry Cohort, Traumatic Brain Injury, AD/MCI

Traumatic Brain Injury 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to join this investigation?

"Clinicaltrials.gov confirms that this medical experiment is actively accepting patients - the trial was initially uploaded on May 1st 2021 and recently updated November 15th 2022."

Answered by AI

Has F18-3F4AP earned regulatory endorsement from the FDA?

"With limited evidence on safety and efficacy, F18-3F4AP received a score of 1 on the risk scale."

Answered by AI

How many individuals are actively participating in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, the advertised study is actively recruiting for 66 participants from a single site. Initially posted on 1/5/2021 and updated most recently on 11/15/2022, this research opportunity may be of interest to you."

Answered by AI

Is the upper age limit for enrolment in this trial greater than 25?

"This trial is open to those aged 18 or older, with the upper limit for enrollment set at 90."

Answered by AI

Am I eligible to become an experimental subject in this clinical research?

"This trial is recruiting 66 people with brain injuries, traumatic aged 18 to 90. To be considered for the study, applicants must meet certain age criteria - they should either be over 18 years of age or between 60 and 90 in cases concerning Alzheimer's disease (AD)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exploring the Utility of [18F]3F4AP for Demyelination Imaging in Controls, Neurodegeneration and Traumatic Brian Injury

Marc D.Normandin, Ph.D 2021. "Exploring the Utility of [18F]3F4AP for Demyelination Imaging in Controls, Neurodegeneration and Traumatic Brian Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04710550.

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