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

February 26, 2024 updated by: Marc A. Seltzer, Dartmouth-Hitchcock Medical Center

Role of NeuraceqTM (Florbetaben F18 Injection) PET in Young Athletes With and Without Persistent Cognitive Complaints Following Multiple Concussions: A Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
Diagnostic test: 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.
Other Names:
  • 18F-Florbetaben
Active Comparator: 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.
Diagnostic test: 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.
Other Names:
  • 18F-Florbetaben

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neuraceq™ PET Imaging
Time Frame: Up to 90 minutes after injection
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
Time Frame: within 24 hours of [F-18]Florbetaben PET imaging
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
Time Frame: within 24 hours of [F-18]Florbetaben PET imaging
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartmouth-Hitchcock Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc A Seltzer, MD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D16096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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