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

Glioma Clinical Trial

Official title:

MC167B: Pilot Study Investigating the Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242824
• Other study ID #: 16-006072
• Secondary ID: MC167BNCI-2017-0
• Status: Completed
• Phase: Phase 2
• Start date: September 29, 2017
• Est. completion date: June 16, 2021

Study information

• Verified date: February 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 16, 2021
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age > or equal to 18 years
• ECOG PS < or equal to 3
• Histologically confirmed or radiographic evidence of recurrent/progressive glioma.
• History of radiation therapy to the brain for prior diagnosis of glioma
• Planned radiation treatments at Mayo Clinic Rochester
• Provide informed written consent
• Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136 (blood draw optional)
• Willing to return to enrolling institution for follow-up during Active Monitoring Phase of the study. Exclusion Criteria
• More than one prior course of radiotherapy or prior prescription doses exceeding 60 Gy to re-irradiation target volumes
• Unable to undergo MRI scans with contrast
• 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.

-Any of the following:

• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• Fluorine F 18 Fluorodopa
Contrast used in PET

Radiation:
• Intensity-Modulated Radiation Therapy
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

Procedure:
• Positron Emission Tomography
imaging test

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Progression-free Survival	measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls	up to 3 months
Secondary	Overall Survival	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	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
Secondary	Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities	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)	up to 2 years
Secondary	Quality of Life Brief Fatigue Index (BFI) Change From Baseline	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.	Baseline and 3 months
Secondary	Re-operative Count	Count of patients that receive re-operation post re-irradiation	up to 2 years
Secondary	Quality of Life MDASI-BT Change From Baseline	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'.	Baseline and 3 months