NCT03778294CompletedPhase 2
18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy
Phase II Study of Short Course Hypofractionated Proton Beam Therapy Incorporating 18F-DOPA-PET/MRI for Elderly Patients With Newly Diagnosed Glioblastoma
Source: ClinicalTrials.gov · Last updated 3 Jul 2025
Brief summary (registry, in English)
This phase II trial studies how well fluorodopa F 18-positron emission tomography/magnetic resonance imaging scan (18F-DOPA-PET/MRI) works in imaging elderly patients with newly diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of proton beam radiation therapy. 18F-DOPA is a chemical tracer that highlights certain cells during imaging. PET scan, is a metabolic imaging technique which takes advantage of how tumor cells take up nutrients differently than normal tissue. MRI scans are used to guide radiation therapy for most brain tumors. Hypofractionated proton beam therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Using 18FDOPA-PET scans along with MRI scans may be able to provide the radiation doctor with information on tumor tissue versus normal, healthy tissue and may help the doctor more accurately plan the radiation treatment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 14 Dec 2018
- Start date
- 28 Mar 2019
- Primary completion date
- 30 Jun 2022
- Lead sponsor
- Mayo Clinic
- Diseases
- Glioblastoma
- NCT number
- NCT03778294
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 43
- From 28 Mar 2019 to the primary completion date, 30 Jun 2022
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on Avastin at time of treatment
Other illness
- 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)
- NOTE: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline. If a patient is on any of these drugs, list which ones on the on-study form
Age
- Pregnant women, nursing women, or men or women of childbearing potential who are unwilling to employ adequate contraception.
- NOTE: All women enrolled in this study will be age 65 or over, and at the determination of the principal investigator (PI), will not be of childbearing potential. If the radiology department requires a pregnancy test before administering the 18FDOPA injection, they may perform one per their standard of care
Other
- Patients diagnosed with grades I-III glioma
Who the study is looking for
- Histologically confirmed newly diagnosed grade IV malignant glioma
- Planned radiation treatments at Mayo Clinic Arizona or Mayo Clinic Rochester
- Willing to sign release of information for any radiation and/or follow-up records
- Provide informed written consent
- Patients with estimated glomerular filtration rate (eGFR) \>= 60 mg/min/1.72 m\^2
- Ability to complete questionnaire(s) by themselves or with assistance
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.