A Study of Fluorine F 18 Fluorodopa-Labeled PET Scans for Planning Surgery and Radiation Therapy to Treat Patients who have Newly Diagnosed High- or Low-Grade Glioma Brain Cancer Tumors

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 10-001904
    NCT ID: NCT01165632
    Sponsor Protocol Number: MC1078

About this study

The purpose of this study is to evaluate the use of fluorine F 18 fluorodopa-labeled PET scanning for the planning of surgery and radiation therapy to treat patients who have newly diagnosed high- or low-grade glioma brain tumors. New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scans, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Age ≥18 years
  • MRI findings compatible with newly diagnosed high- or low-grade malignant glioma
  • Planned craniotomy and resection or biopsy
  • Willing to sign release of information for any radiation and/or follow-up records
  • Negative pregnancy test done ≤ 48 hours of injection of study drug, for women of childbearing potential only
  • Provide informed written consent
  • eGFR < 60 mg/min/1.72m2 is eligible for the study
    • Is not eligible to receive the contrast for the pMRI at the study dose

Exclusion Criteria

  • Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
  • Unable to undergo an 18F-FDOPA PET scan (e.g. Parkinson's Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)
  • Pregnant 
  • Nursing 
  • Men or women of childbearing potential who are unwilling to employ adequate contraception

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Debra Brinkmann, Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20314928

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