Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Fluorodopa F 18 | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Proton Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
- description
- Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Procedure: Computed Tomography
- Other: Fluorodopa F 18
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Radiation: Proton Beam Radiation Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Time from registration to death due to any cause, assessed up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients diagnosed with grades I-III glioma * Currently on Avastin at time of treatment * 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 * 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
References
Publications (1)
- DERIVEDVora S, Pafundi D, Voss M, Buras M, Ashman J, Bendok B, Breen W, Hu L, Kizilbash S, Laack N, Liu W, Mahajan A, Mrugala M, Porter A, Ruff M, Sio T, Uhm J, Yang M, Brinkmann D, Brown P. Short-course hypofractionated proton beam therapy, incorporating 18F-DOPA PET and contrast-enhanced MRI targeting, for patients aged 65 years and older with newly diagnosed glioblastoma: a single-arm phase 2 trial. Lancet Oncol. 2024 Dec;25(12):1625-1634. doi: 10.1016/S1470-2045(24)00585-0. Epub 2024 Nov 18. PMID 39571596