Evaluating the Impact of 18F-DOPA-PET on Radiotherapy Planning for Newly Diagnosed 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: 13-005106
NCT ID: NCT01991977
Sponsor Protocol Number: MC1374
About this study
The purpose of this study is to use a nutrient called 18F-FDOPA and PET/CT scan to help determine where and how big the tumor is, as well as how aggressive the tumor is. This will help treating physicians to target diseased areas with higher than standard doses of 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.
- Histologically confirmed newly diagnosed high-grade malignant glioma.
- Planned radiation treatments at Mayo Clinic Rochester.
- Willing to sign release of information for any radiation and/or follow-up records.
- Provide informed written consent.
- Patients with eGFR ≥ 60 mg/min/1.72m2
- Ability to complete questionnaire(s) by themselves or with assistance.
- Patients diagnosed with anaplastic oligodendroglioma
- 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)
- Any of the following:
- 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.
|Mayo Clinic Location
Mayo Clinic principal investigator
Debra Brinkmann, Ph.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office