Trial | NCT02104310  Report issue

Title

A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas
A Pilot Study Evaluating the Utility of 18F-DOPA PET for Radiotherapy Treatment Planning of Malignant Glioma Patients

  • Phase

    Phase 2

  • Study Type

    Observational

  • Status

    Active, not recruiting

  • Intervention/Treatment

    fluorodopa ...

  • Study Participants

    25
For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most aggressive regions of the tumor. The goal of this study is to compare the 18F-DOPA PET/CT scan with the MRI scan for identifying where the disease is that needs to be treated with radiation.
Study Started
Apr 30
2014
Primary Completion
Mar 26
2021
Study Completion
Mar 31
2031
Anticipated
Last Update
Oct 19
2023

Drug Fluorine-18-L-dihydroxyphenylalanine

5 millicuries ± 10%; Intravenous injection; 1 time

  • Other names: 18F-DOPA, FDOPA

Fluorine-18-L-dihydroxyphenylalanine None

18F-DOPA PET imaging will be used to guide radiotherapy treatment volumes and patients will be followed post-treatment to analyze response and patterns of failure

Population

Newly diagnosed or recurrent WHO Grade II and Grade III Glioma patients.

Criteria 

Inclusion Criteria:

Age ≥7 years.
Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma.
CT simulation, 18F-DOPA PET imaging, and standard of care pre-radiotherapy MRI scans to be performed at Mayo Clinic Rochester.
Willing to sign release of information for any follow-up records.
Provide informed written consent.

Exclusion Criteria:

Patients diagnosed with WHO grade IV malignant glioma.
Patients previously treated with radiation therapy.
Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure).
Unable to undergo an 18F-DOPA 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
No Results Posted