A Pilot Study Using 18F-DOPA PET-guided Radiotherapy in Gliomas
Study type: Interventional What is this?
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.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 11-002165
NCT ID: NCT02104310
Sponsor Protocol Number: 11-002165
About this study
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 to image the tumor and guide your radiation oncologist in determining locations to treat with radiation. 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 use the 18F-DOPA PET/CT scan to help determine where the disease is that needs to be treated with radiation, in order to improve the effectiveness of radiation in this tumor.
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
- Age ≥18 years.
- Biopsy confirmed newly diagnosed or recurrent WHO Grade II or Grade III malignant glioma, or Grade III malignant astrocytoma or oligoastrocytoma.
- Planned radiation treatments at Mayo Clinic Rochester.
- Willing to sign release of information for any follow-up records.
- Provide informed written consent.
- Willingness to participate in mandatory pre- and post-treatment imaging studies.
- Patients diagnosed with WHO grade III oligodendroglioma or 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.