CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Temozolomide +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03778294
NCT03778294Phase 2Completed

Phase II Study of Short Course Hypofractionated Proton Beam Therapy Incorporating 18F-DOPA-PET/MRI for Elderly Patients With Newly Diagnosed Glioblastoma

Mayo Clinic·interventional·Posted Dec 19, 2018·Updated Jul 3, 2025

In Brief

A Phase 2 clinical trial evaluating Computed Tomography, Fluorodopa F 18, and 6 other interventions for Glioblastoma and Malignant Glioma. Completed, enrolled 43 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 19, 2018
Enrollment StartMar 28, 2019
Primary CompletionJun 30, 2022
Study CompletionNov 26, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.5 years ago

Interventions

Computed Tomographyprocedure

Undergo PET/CT

Fluorodopa F 18other

Given IV

Magnetic Resonance Imagingprocedure

Undergo PET/MRI

Positron Emission Tomographyprocedure

Undergo PET/CT or PET/MRI

Proton Beam Radiation Therapyradiation

Receive proton beam RT

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Temozolomidedrug

Drug