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

NCT01165632 | Completed Early Phase 1 DMC

• 3 other identifiers: MC1078NCI-2010-0160710-001904
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies

  Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.

  Up to 2 years

• 18F- FDOPA-PET metabolic imaging information

  Compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.

  Up to 2 years

Secondary Outcomes (3)

• Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies

  Up to 2 years

• With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information

  2 Years

• 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies

  2 years

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Procedure: biopsy; Procedure: computed tomography; Procedure: therapeutic conventional surgery; Radiation: radiation therapy treatment planning/simulation; Radiation: radiation therapy; Procedure: magnetic resonance imaging; Procedure: positron emission tomography; Drug: fluorine F 18 fluorodopa

Interventions

biopsy PROCEDURE

Correlative studies

Also known as: biopsies

Arm I

computed tomography PROCEDURE

Undergo computed tomography

Also known as: tomography, computed

Arm I

therapeutic conventional surgery PROCEDURE

Undergo stereotactic craniotomy

Arm I

radiation therapy treatment planning/simulation RADIATION

Undergo radiation therapy treatment planning/simulation

Arm I

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Arm I

magnetic resonance imaging PROCEDURE

Undergo magnetic resonance imaging

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Arm I

positron emission tomography PROCEDURE

Undergo positron emission tomography

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Arm I

fluorine F 18 fluorodopa DRUG

Given IV

Also known as: (18)F-FDOPA, 18F-6- L-fluorodopa, 18F-DOPA, 18F-FDOPA

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Astrocytoma; Ependymoma; Oligodendroglioma; Glioblastoma; Gliosarcoma; Glioma; Glioma, Subependymal

Interventions

Biopsy; Radiotherapy; Radiation; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; fluorodopa F 18

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Therapeutics; Physical Phenomena; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Nadia N. Laack, M.D.

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 20, 2010
• Study Start: July 26, 2010
• Primary Completion: November 5, 2013
• Study Completion: July 26, 2019
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)