Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion

NCT05270083 | Completed

• 1 other identifier: D16096
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to learn if Neuraceq™ (Florbetaben F 18 Injection) PET can detect changes in the brains of young athletes who sustained one or more concussions with or without persistent cognitive complaints at least 5 years after injury.

Conditions

Concussion, Brain

Outcome Measures

Primary Outcomes (3)

• Neuraceq™ PET Imaging

  Participants will receive an intravenous (IV) dose of 300 MBq of Neuraceq™ (\[F-18\]Florbetaben) in a volume of 10 mL or less. A 30 minute duration PET image will be acquired starting immediately after Neuraceq™ injection. A second 20-minute duration PET image will be acquired starting 90 minutes after Neuraceq™ injection. Imaging data will be reconstructed using standard iterative reconstruction algorithm and with CT-based attenuation correction. Images will be interpreted both visually and semi-quantitatively (cortical-to-cerebellum standardized uptake value rations) for 6 target cortical regions of interest (frontal, temporal, parietal, anterior cingulate, posterior cingulate, and precuneus), using the whole cerebellum as the reference region.

  Up to 90 minutes after injection

• Cognitive Assessment_1

  Participants will complete a set of cognitive questionnaires to assess presence or absence of cognitive complaints. Altered cognitive performance will be defined as either one score of more than 2 standard deviations or two scores of 1 standard deviation below the age-adjusted norm or estimates of baseline premorbid function (using the Barona Index) on tests of attention and/or memory.

  within 24 hours of [F-18]Florbetaben PET imaging

• Cognitive Assessment_2

  Participants will complete a set of cognitive questionnaires to assess presence or absence of cognitive complaints. Significant cognitive complaints will be defined as scores of 1 standard deviation below the mean on the Multiple Ability Self-Report Questionnaire (MASQ).

  within 24 hours of [F-18]Florbetaben PET imaging

Study Arms (2)

Athletes with mild to moderate traumatic brain injury (mTBI) and good outcome

ACTIVE COMPARATOR

Young athletes who have sustained one or more concussions without persistent cognitive complaints at least one year post-injury

Diagnostic Test: NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben)

Athletes with persistent cognitive deficits due to mild to moderate traumatic brain injury (mTBI)

ACTIVE COMPARATOR

Young athletes who have sustained one or more concussions with persistent cognitive complaints at least one year post-injury in spite of medical and cognitive treatment intervention.

Diagnostic Test: NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben)

Interventions

NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben) DIAGNOSTIC_TEST

Participants will receive an intravenous (IV) dose of 300 MBq of Neuraceq™ in a volume of 10 mL or less. A 30 minute duration PET image will be acquired starting immediately after Neuraceq™ injection. A second 20-minute duration PET image will be acquired starting 90 minutes after Neuraceq™ injection.

Also known as: 18F-Florbetaben

Athletes with mild to moderate traumatic brain injury (mTBI) and good outcome; Athletes with persistent cognitive deficits due to mild to moderate traumatic brain injury (mTBI)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• A minimum of 1 concussion prior to study entry
• A minimum of one year post first concussion
• mTBI as defined by the American Congress of Rehabilitative Medicine
• Participants in Cohort A must have either subjective or objective evidence of persistent cognitive deficits

You may not qualify if:

• Impaired decision-making capacity, i.e. inability to provide informed consent
• Pregnancy
• History of other neurologic disorders (e.g., epilepsy, cerebrovascular disease, neurodegenerative disorders, intellectual disability)
• Significant systemic medical illness
• Current DSM-IV Axis I diagnosis of psychiatric illness

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Marc A Seltzer, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Section Chief, Diagnostic Radiology

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 8, 2022
• Study Start: July 13, 2017
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)