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F-18 3F4AP Imaging for Multiple Sclerosis

Phase 1
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to understand and provide informed consent prior to study procedures
Subjects must be ≥18 and <65 years of age;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing the safety and efficacy of using a new imaging agent, [18F]3F4AP, to visualize demyelinating diseases such as multiple sclerosis. The goal is to see if this agent can help assess disease severity and progression, and to see if it can help guide treatment decisions.

Who is the study for?
This trial is for adults aged 18 to 65 with or without multiple sclerosis (MS) who can consent to the study. It excludes those with brain diseases like tumors or stroke, MRI/PET contraindications such as metal implants, severe claustrophobia, certain chronic diseases, allergy to contrast agents used in imaging, excessive prior radiation exposure, pregnant or lactating women, and any unstable health conditions.Check my eligibility
What is being tested?
[18F]3F4AP is being tested for its ability to image demyelination in MS using PET scans. The study will check if it's safe for humans; compare how it moves through the body of healthy people versus those with MS; ensure consistent results on repeated tests; match PET images with MRI findings and correlate them with neuropsychological test scores and disability levels in MS patients.See study design
What are the potential side effects?
Potential side effects are not specified but will be monitored by changes in vital signs and other adverse events during the trial. Since [18F]3F4AP is a tracer used in imaging studies rather than a drug treatment, fewer side effects are expected compared to typical medication trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study and can give my consent.
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I am between 18 and 64 years old.
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I am between 18 and 65 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Binding of 18-F 3F4AP in the brain of healthy volunteers and multiple sclerosis subjects
Number of participants with adverse events related to tracer administration as assessed by CTCAE v4.0
Secondary outcome measures
Brain
Within-subject variability in healthy controls and multiple sclerosis subjects

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Multiple sclerosisExperimental Treatment1 Intervention
F-18 3F4AP PET Scan
Group II: Healthy controlsActive Control1 Intervention
F-18 3F4AP PET Scan

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
2,929 Previous Clinical Trials
13,198,245 Total Patients Enrolled
9 Trials studying Multiple Sclerosis
1,909 Patients Enrolled for Multiple Sclerosis

Media Library

F-18 3F4AP Clinical Trial Eligibility Overview. Trial Name: NCT04699747 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned F-18 3F4AP for medical use?

"Based on our assessment at Power, the safety of F-18 3F4AP is rated as 1 because this clinical trial is in its first phase; therefore there are only limited data sources to evaluate safety and efficacy."

Answered by AI

How many participants are there for this therapeutic exploration?

"Affirmative. According to clinicaltrials.gov, this research project is still in need of participants and was first published on March 25th 2021 with the latest update taking place October 7th 2022. Altogether 60 patients from a single institution are welcomed into the study."

Answered by AI

Does this experimental program permit octogenarians to be enrolled?

"This research study is open to participants that are of legal age and have not yet reached the retirement threshold."

Answered by AI

Do I qualify to join the research trial?

"We are looking for 60 volunteers with multiple sclerosis who meet the following qualifications: between 18 and 65 years of age, capable of understanding the requirements of this trial and providing informed consent."

Answered by AI

Are there still vacancies available for individuals to join this trial?

"According to clinicaltrials.gov, this investigation is currently recruiting patients and was initially posted on March 25th 2021 before being modified most recently on October 7th 2022."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects
Pedro Brugarolas 2021. "Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04699747.
All > Multiple Sclerosis
~10 spots leftby Nov 2024
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