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Completed

NCT Number: NCT03242824

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

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.

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Key information

Conditions

Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorine F 18 Fluorodopa

Drug

Contrast used in PET

Other names: 18F- FDOPA, 3,4-dihydroxy-6-[18F] fluoro-L-phenylalanine

Intensity-Modulated Radiation Therapy

Radiation

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

Other names: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Positron Emission Tomography

Procedure

imaging test

Other names: PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography

Primary outcomes

  1. Proportion of Participants With Progression-free Survival

    Time frame: up to 3 months

    measured by reviewing 18F-DOPA-PET and conventional MRI with historical controls

Secondary outcomes

  1. Overall Survival

    Time frame: 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

  2. Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities

    Time frame: 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)

  3. Quality of Life Brief Fatigue Index (BFI) Change From Baseline

    Time frame: 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.

  4. Re-operative Count

    Time frame: up to 2 years

    Count of patients that receive re-operation post re-irradiation

  5. Quality of Life MDASI-BT Change From Baseline

    Time frame: 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'.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Aug 8, 2017
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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