Back to results

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

Primary Purpose

Glioma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fluorine F 18 Fluorodopa

Intensity-Modulated Radiation Therapy

Positron Emission Tomography

About this trial

This is an interventional treatment trial for Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DOPA PET

Arm Description

Patients will receive 18FDOPA-PET for radiation treatment planning

Outcomes

Primary Outcome Measures

Proportion of Participants With Progression-free Survival

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

Secondary Outcome Measures

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

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)

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.

Re-operative Count

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

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'.

Full Information

NCT ID

NCT03242824

First Posted

August 2, 2017

Last Updated

March 10, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03242824

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

September 29, 2017 (Actual)

Primary Completion Date

June 16, 2020 (Actual)

Study Completion Date

June 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

18F-DOPA PET

Arm Type

Experimental

Arm Description

Patients will receive 18FDOPA-PET for radiation treatment planning

Intervention Type

Drug

Intervention Name(s)

Fluorine F 18 Fluorodopa

Other Intervention Name(s)

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

Intervention Description

Contrast used in PET

Intervention Type

Radiation

Intervention Name(s)

Intensity-Modulated Radiation Therapy

Other Intervention Name(s)

IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography

Intervention Description

imaging test

Primary Outcome Measure Information:

Title

Proportion of Participants With Progression-free Survival

Description

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

Time Frame

up to 3 months

Secondary Outcome Measure Information:

Title

Overall Survival

Description

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

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

Title

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

Description

Time Frame

up to 2 years

Title

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

Description

Time Frame

Baseline and 3 months

Title

Re-operative Count

Description

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

Time Frame

up to 2 years

Title

Quality of Life MDASI-BT Change From Baseline

Description

Time Frame

Baseline and 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadia N Laack

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs