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Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 10 months later Nov 30, 2026 → Sep 30, 2028
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Record History

  1. Notable Primary and study completion pushed from Nov 30, 2026 to Sep 30, 2028 Eligibility criteria expanded, about 19 words · Secondary endpoints: details revised at 2 of 2 entries · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 1 of 1 entry
  2. Notable Primary and study completion dates: Nov 30, 2024 to Nov 30, 2026v8
  3. Minor 2 versions Re-verified since Oct 7, 2022, no change to tracked fieldsv6-v7
  4. Notable Primary endpoints revised (2)v5 See this version in full on ClinicalTrials.gov ↗
  5. Minor Start date changed from estimate of Mar 15, 2021 to Mar 25, 2021v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Jan 20, 2021 to Mar 15, 2021v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Jan 1, 2021 to Jan 20, 2021 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Jan 1, 2021 to Jan 20, 2021
    • Site details revised
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04699747
Lead Sponsor Massachusetts General Hospital
Conditions Multiple Sclerosis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov