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

NCT03242824 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 16-006072MC167BNCI-2017-02479
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Progression-free Survival

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

  up to 3 months

Secondary Outcomes (5)

• 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

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

  up to 2 years

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

  Baseline and 3 months

• Re-operative Count

  up to 2 years

• Quality of Life MDASI-BT Change From Baseline

  Baseline and 3 months

Study Arms (1)

18F-DOPA PET

EXPERIMENTAL

Patients will receive 18FDOPA-PET for radiation treatment planning

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

Interventions

Fluorine F 18 Fluorodopa DRUG

Contrast used in PET

Also known as: 18F- FDOPA, 3,4-dihydroxy-6-[18F] fluoro-L-phenylalanine

18F-DOPA PET

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

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

18F-DOPA PET

Positron Emission Tomography PROCEDURE

imaging test

Also known as: PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography

18F-DOPA PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

fluorodopa F 18; Radiotherapy, Intensity-Modulated; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Nadia N. Laack, MD, MS
• Organization: Mayo Clinic

Laack.Nadia@mayo.edu

507/284-2511

Study Officials

• Nadia N Laack

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 8, 2017
• Study Start: September 29, 2017
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2021
• Last Updated: March 14, 2023
• Results First Posted: July 5, 2022

Record last verified: 2023-02

Locations

US (1)