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Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma

Study Purpose

RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment. PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.
  • - Patients with eGFR < 60 mg/min/1.72m2 are eligible for the study; PLEASE NOTE: the patient 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 women; nursing women; men or women of childbearing potential who are unwilling to employ adequate contraception

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01165632
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Nadia N. Laack, M.D.
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Ependymoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Adult Myxopapillary Ependymoma, Adult Oligodendroglioma, Adult Pilocytic Astrocytoma, Adult Pineal Gland Astrocytoma, Adult Subependymal Giant Cell Astrocytoma, Adult Subependymoma
Study Website: View Trial Website
Additional Details

PRIMARY OBJECTIVES:

  • I. To determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.
  • II. To compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
SECONDARY OBJECTIVES:
  • I. To determine correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.
OUTLINE: Beginning at no more than 1 week before biopsy and resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy. After completion of study treatment, patients are followed up every year for 5 years.

Arms & Interventions

Arms

Experimental: Arm I

Beginning at no more than 1 week before biopsy or resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.

Interventions

Procedure: - biopsy

Correlative studies

Procedure: - computed tomography

Undergo computed tomography

Procedure: - therapeutic conventional surgery

Undergo stereotactic craniotomy

Radiation: - radiation therapy treatment planning/simulation

Undergo radiation therapy treatment planning/simulation

Radiation: - radiation therapy

Undergo radiation therapy

Procedure: - magnetic resonance imaging

Undergo magnetic resonance imaging

Procedure: - positron emission tomography

Undergo positron emission tomography

Drug: - fluorine F 18 fluorodopa

Given IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Address

Mayo Clinic

Rochester, Minnesota, 55905

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