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

Adult Glioblastoma Clinical Trial

Official title:

A Pilot Study of Utility of 18F-FDOPA-PET for Neurosurgical Planning and Radiotherapy Target Delineation in Glioma Patients: Biopsy Validation of 18F-FDOPA-PET Uptake and Biodistribution in Brain Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01165632
• Other study ID #: MC1078
• Secondary ID: NCI-2010-0160710
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: July 26, 2010
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 30, 2024
• Est. primary completion date: November 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Astrocytoma
• Ependymoma
• Glioblastoma
• Glioma
• Gliosarcoma
• Oligodendroglioma

Intervention

Procedure:
• biopsy
Correlative studies
• computed tomography
Undergo computed tomography
• therapeutic conventional surgery
Undergo stereotactic craniotomy

Radiation:
• radiation therapy treatment planning/simulation
Undergo radiation therapy treatment planning/simulation
• radiation therapy
Undergo radiation therapy

Procedure:
• magnetic resonance imaging
Undergo magnetic resonance imaging
• positron emission tomography
Undergo positron emission tomography

Drug:
• fluorine F 18 fluorodopa
Given IV

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies	Determine correlation between concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.	Up to 2 years
Secondary	With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information	Compare radiotherapy target volume delineation with and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information; pMRI and DTI advanced MR imaging, to determine role in radiotherapy treatment planning.	2 Years
Secondary	18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies	Determine correlation between 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies.	2 years