NCT04710550 is a Phase 1 clinical trial of F18-3F4AP in Brain Injuries, Traumatic, sponsored by Massachusetts General Hospital.

Who is sponsoring NCT04710550?

NCT04710550 is sponsored by Massachusetts General Hospital.

What drugs are being tested in NCT04710550?

Interventions in NCT04710550: F18-3F4AP.

What condition does NCT04710550 study?

NCT04710550 studies Brain Injuries, Traumatic, Demyelinating Disorder, Alzheimer Disease.

Is NCT04710550 still recruiting?

NCT04710550 is currently status unknown. Last updated 30 January 2024.

Last reviewed 2024-01-30 · How we verify

NCT04710550

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 1 Last updated 30 January 2024

What this trial tests

Phase 1 trial testing F18-3F4AP in Brain Injuries, Traumatic in 8 participants. Status unknown.

Timeline

25 January 2021

Primary endpoint
1 December 2025

1 December 2025

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	8
Start date	25 January 2021
Primary completion	1 December 2025
Estimated completion	1 December 2025
Sites	1 location across United States

Drugs / interventions tested

F18-3F4AP — full drug profile →

Conditions studied

Brain Injuries, Traumatic — all drugs for Brain Injuries, Traumatic →
Demyelinating Disorder — all drugs for Demyelinating Disorder →
Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 90, any sex, with Brain Injuries, Traumatic or Demyelinating Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Current Clinical Trials in Traumatic Brain Injury.
Ahmed Z. · · 2022 · cited 23× · PMID 35624914 · DOI 10.3390/brainsci12050527
Human biodistribution and radiation dosimetry of the demyelination tracer [18F]3F4AP.
Brugarolas P, Wilks MQ, Noel J, Kaiser JA, et al · · 2023 · cited 17× · PMID 36197499 · DOI 10.1007/s00259-022-05980-w
Common anesthetic used in preclinical PET imaging inhibits metabolism of the PET tracer [18F]3F4AP.
Ramos-Torres K, Sun Y, Takahashi K, Zhou YP, et al · · 2024 · cited 5× · PMID 38690718 · DOI 10.1111/jnc.16118
Proceedings of the World Molecular Imaging Congress 2021, October 5-8, 2021: Late-Breaking Abstracts.
· 2021 · cited 2× · PMID 34982366 · DOI 10.1007/s11307-021-01694-x
Radiosynthesis automation, non-human primate biodistribution and dosimetry of K+ channel tracer [11C]3MeO4AP.
Zhou YP, Wilks MQ, Dhaynaut M, Guehl NJ, et al · · 2024 · cited 1× · PMID 38683467 · DOI 10.1186/s13550-024-01092-8
Translational molecular imaging and drug development in multiple sclerosis.
Tay D, Ahmed H, Dawoud A, Salam M, et al · · 2026 · PMID 41356192 · DOI 10.7150/thno.119559
Human biodistribution and radiation dosimetry of the demyelination tracer [18F]3F4AP
Brugarolas P, Wilks MQ, Noel J, Kaiser J, et al · · 2022 · DOI 10.1101/2022.05.21.22275275

Verify or expand the search:

Other recruiting trials for Brain Injuries, Traumatic

Currently open trials in the same condition.

NCT06898242 — Early Myofascial Manual Treatment in Subjects With Spasticity Following Acquired Brain Injury · NA · active not recruiting
NCT06413173 — Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric) · NA · recruiting
NCT06142435 — mTBI Identification and Monitoring Through Retinal Scanning · recruiting
NCT05117619 — The HOME Program for Individuals With Traumatic Brain Injury and Family Members · NA · recruiting
NCT05092295 — Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury · active not recruiting

Other Massachusetts General Hospital trials

Trials by the same sponsor.

NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04710550 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 30 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04710550.

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