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

NCT ID: NCT05270083

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-13
• Study Completion Date: 2019-10-10

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.

Detailed Description

Former college athletes who sustained at least one previous concussion will undergo computerized neurocognitive testing and a structured questionnaire of present symptoms. [F-18] Florbetaben PET images will be acquired dynamically, with data binned in 20 time frames of 1 min each (early phase), followed by 4 frames of 5 min each (late phase), with image frames summed within each phase after linearly coregistering to subjects' mean images, then elastically transformed to template space of a florbetaben scan used in standardized volume of interest quantification, and intensity normalized to mean voxel value within each phase.

Conditions

Concussion, Brain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

18F-Florbetaben

Eligibility Criteria

Inclusion Criteria

• 18-40 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Marc A. Seltzer

Principal Investigator, Section Chief, Diagnostic Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc A Seltzer, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D16096

Identifier Type: -

Identifier Source: org_study_id