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

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ClinicalTrials.gov Identifier: NCT04710550
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Georges El Fakhri, Massachusetts General Hospital

Study Description
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Brief Summary:

The overall objective is to obtain an initial assessment of the value of using [18F]3F4AP for imaging demyelinating diseases such as traumatic brain injury (TBI), neurodegenerative diseases such as mild cognitive impairment (MCI) and Alzheimer's Disease (AD):

  • Aim 1) Assess the safety of [18F]3F4AP in healthy volunteers and subjects with traumatic brain injury (TBI) and neurocognitive impaired subjects (AD/MCI). Hypothesis 1: Administration of [18F]3F4AP will result in no changes in vitals or other adverse events.
  • Aim 2) Assess the radiation doses to the main organs in healthy volunteers. Hypothesis 2: the radiation doses to each organ will be comparable in all subjects and within the acceptable limits.
  • Aim 3) Assess the pharmacokinetics of a bolus infusion of [18F]3F4AP in humans including healthy volunteers and patients. Hypothesis 3: the pharmacokinetics of [18F]3F4AP at the whole brain level will be similar in controls, TBI and AD/MCI subjects. The kinetics in demyelinated lesions will be slower than in healthy areas.
  • Aim 4) Correlate MR images with [18F]3F4AP PET 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 TBI and AD/MCI. Hypothesis 5A: increased PET signal (VT or SUV) will correlate with impaired Mini Mental State Examination (MMSE).

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Demyelinating Disorder Alzheimer Disease Drug: F18-3F4AP Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exploring the Utility of [18F]3F4AP for Demyelination Imaging in Controls, Neurodegeneration and Traumatic Brian Injury
Actual Study Start Date : January 5, 2021
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Safety/Dosimetry Cohort Drug: F18-3F4AP
PET Scan
Experimental: Traumatic Brain Injury Drug: F18-3F4AP
PET Scan
Experimental: AD/MCI Drug: F18-3F4AP
PET Scan
Active Comparator: Healthy Controls Drug: F18-3F4AP
PET Scan


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 5 years ]
    Determine number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects are 18 years of age and older, except AD subjects who are 60 to 90 years of age.

Exclusion Criteria:

  • A subject will not be eligible for inclusion in this study if any of the exclusion criteria for PET/CT or MRI studies applies. A negative STAT quantitative serum hCG pregnancy test is required on the day of the PET/CT scan before female subjects of childbearing potential can participate. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04710550


Contacts
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Contact: Georges El Fakhri, PhD 617-726-9640 ELFAKHRI.GEORGES@MGH.HARVARD.EDU

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Julia-Ann Scotton, BS    617-643-1967      
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Georges El Fakhri, PhD Mass. General Hospital
More Information
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Responsible Party: Georges El Fakhri, Director, Gordon Center for Medical Imaging, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04710550    
Other Study ID Numbers: 2020P002254
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georges El Fakhri, Massachusetts General Hospital:
3F4AP
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Injuries
Brain Injuries, Traumatic
Demyelinating Diseases
Nerve Degeneration
Wounds and Injuries
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System
Pathologic Processes