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NCT Number: NCT04383808

Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR

The primary goal of this project is to study the feasibility of a brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of human brains. The study will also allow us to compare the imaging performance of the investigator's brain-dedicated PET insert against a commercial whole-body permanently integrated PET/MRI system using a common radiopharmaceutical.

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Key information

Conditions

Brain Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94305, United States

Location status: Recruiting

Location contact

Paul Newswanger, MPH

CONTACT

[email protected]

650-736-1349

About this study

This study will enroll up to 40 participants.

  • 20 participants at Stanford injected with an FDA-approved PET tracer (e.g. amyloid, FDG, etc.), and
  • 20 participants from Stanford who have been pre-injected with a radiopharmaceutical for a study on another PET imaging system

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Whole body radiation dose within the last year of less than 5000 mrem
  • Subjects intended for injected tracer studies (not associated with another study) must be willing/able to undergo injection of 6-12 mCi of either FDG or Neuraceq radiotracer. Both tracers are FDA approved
  • Subjects will be at least 21 years of age
  • Subject provides written informed consent
  • Subject is deemed healthy by the PI by via self-reported questionnaire

Exclusion criteria

  • For patients who will be receiving a tracer injection, no known allergy to the imaging agents
  • Participant has a history of or current diagnosis of cancer
  • Participant is pregnant or nursing
  • Metallic implants (contraindicated for MRI)

Treatment and study plan

Injected radiotracer with PET Insert

Diagnostic Test
  • Informed consent will be obtained before beginning any study procedures.
  • Participants will receive a small quantity of an FDA approved radiotracer. The PET insert is placed within a 3T MRI scanner, where PET and MRI imaging will be completed.

Pre-injected group with PET insert

Diagnostic Test
  • Informed consent will be obtained before beginning any study procedures.
  • Participants who have received radiotracer for another PET imaging system. The PET insert is placed within a 3T MRI scanner, where PET and MRI imaging will be completed.

Primary outcomes

  1. PETMR image

    Time frame: Up to 24 months

    The key specific measurement is the resulting PET/MR image obtained from the single subject scan.

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Newswanger

CONTACT

[email protected]

(650) 736-1349

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 12, 2020
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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