At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 21 enrolled
Drug / intervention
Fluorine F 18 Fluorodopa +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
- ✓Age 18 years or older
- ✓ECOG performance status 0-3
- ✓Histologically confirmed or radiographic evidence of recurrent/progressive glioma
- ✓History of prior brain radiation for glioma
Key exclusion· 7
- ✕More than one prior course of radiotherapy to brain
- ✕Prior radiation doses exceeding 60 Gy to re-irradiation target volumes
- ✕Unable to undergo MRI with contrast
- ✕Unable to undergo 18F-DOPA-PET scan due to Parkinson's Disease, dopaminergic medications, or recent dopamine agonist use
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
MC167B: Pilot Study Investigating the Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
In Brief
A Phase 2 clinical trial evaluating Fluorine F 18 Fluorodopa, Intensity-Modulated Radiation Therapy, and 1 other intervention for Glioma. Completed, enrolled 21 participants across 1 site.
Detailed Summary
This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast enhancement and T2 FLAIR on MRI. Investigators then plan to compare patterns of failure with target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioma
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2017
Primary CompletionJun 2020
Study CompletionJun 2021
TodayJul 2026
First PostedAug 8, 2017
Enrollment StartSep 29, 2017
Primary CompletionJun 16, 2020
Study CompletionJun 16, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.9 years ago
Interventions
Fluorine F 18 Fluorodopadrug
Contrast used in PET
Intensity-Modulated Radiation Therapyradiation
Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor
Positron Emission Tomographyprocedure
imaging test