The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma

Phase 2

Completed

• Conditions: Glioma
• Interventions: Drug: Fluorine F 18 Fluorodopa; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Positron Emission Tomography

• Registration Number: NCT03242824
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-08
• Study Start: 2017-09-29
• Primary Completion: 2020-06-16
• Study Completion: 2021-06-16
• Results First Submitted: 2021-09-23
• Results First Submitted QC: 2022-06-30
• Results First Posted: 2022-07-05
• Status Verified: 2023-02
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-DOPA PET	Positron Emission Tomography	Patients will receive 18FDOPA-PET for radiation treatment planning
18F-DOPA PET	Fluorine F 18 Fluorodopa	Patients will receive 18FDOPA-PET for radiation treatment planning
18F-DOPA PET	Intensity-Modulated Radiation Therapy	Patients will receive 18FDOPA-PET for radiation treatment planning

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Progression-free Survival	up to 3 months	measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls

Secondary Outcome Measures

Name	Time	Method
Quality of Life Brief Fatigue Index (BFI) Change From Baseline	Baseline and 3 months	Measured by change from baseline to 3 month evaluation in MDA-BFI global fatigue score. Brief fatigue index is a QOL questionnaire with scores ranging from 0, no fatigue, to 10, as bad as you can imagine.
Overall Survival	From date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. Diagnosis date occurs prior to randomization by up to 15 years	Overall survival from initial diagnosis: Time from initial diagnosis to death from any cause censoring patients alive at their last follow-up, assessed up to 2 years from date of randomization
Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities	up to 2 years	The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site:(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm)
Re-operative Count	up to 2 years	Count of patients that receive re-operation post re-irradiation
Quality of Life MDASI-BT Change From Baseline	Baseline and 3 months	QOL will be evaluated using the MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) and fatigue will be evaluated using the MD Anderson Brief Fatigue Inventory.Measured by change from baseline to 3 month evaluation in MDASI-BT overall symptom distress score. Scores may range from 0 to 10, with 0 being 'Not present' and 10 being 'As bad as imaginable'.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States