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NCT04699747 · ClinicalTrials.gov registry record · Phase 1
Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects
A Phase 1 study of Multiple Sclerosis, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04699747 is a Phase 1 study of Multiple Sclerosis that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 60 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04699747, a Phase 1 study of Multiple Sclerosis, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Our overall objective is to obtain an initial assessment of the potential value of using \[18F\]3F4AP for imaging demyelinating diseases such as multiple sclerosis: * Aim 1) Assess the safety of \[18F\]3F4AP in healthy volunteers and subjects with multiple sclerosis (MS). Hypothesis 1: Administration of \[18F\]3F4AP will result in no changes in vitals or other adverse events. * Aim 2) Assess the pharmacokinetics of a bolus infusion of \[18F\]3F4AP in humans including healthy volunteers and MS patients. Hypothesis 2: the pharmacokinetics of \[18F\]3F4AP at the whole brain level will be similar in controls and MS subjects. The kinetics in demyelinated lesions will be slower than in healthy control areas. * Aim 3) Assess the reproducibility of \[18F\]3F4AP in humans. Hypothesis 3: the test/retest variability of \[18F\]3F4AP within the same subject will be lower than 10%. * Aim 4) Correlate MR brain images with \[18F\]3F4AP PET brain images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all. * Aim 5) Correlate \[18F\]3F4AP PET signal with neuropsychological testing in people with MS. Hypothesis 5: increased PET signal (VT or SUV) will correlate with impaired Single Digit Modality Test (SDMT) scores. * Aim 6) Correlate \[18F\]3F4AP PET signal with EDSS score in people with MS. Hypothesis 6: increased PET signal (VT or SUV) will correlate with higher EDSS scores.
Conditions Studied
Interventions
- DRUG F-18 3F4AP
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-03-25 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04699747
The ClinicalTrials.gov registry entry for NCT04699747 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (90% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which F-18 3F4AP is the first listed.
NCT04699747 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04699747 about?
NCT04699747 is a clinical study titled "Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects". Our overall objective is to obtain an initial assessment of the potential value of using \[18F\]3F4AP for imaging demyelinating diseases such as multiple sclerosis: * Aim 1) Assess the safety of \[18F\]3F4AP in healthy volunteers and subjects with multiple sclerosis (MS). Hypothesis 1: Administrati...
What is the current status of trial NCT04699747?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-03-25. Estimated completion is 2026-11-30.
What conditions does trial NCT04699747 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT04699747?
The interventions under investigation include: F-18 3F4AP (DRUG).
Who is sponsoring clinical trial NCT04699747?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04699747 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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