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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03242824
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma	Drug: Fluorine F 18 Fluorodopa; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Positron Emission Tomography	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MC167B: Pilot Study Investigating the Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
• Actual Study Start Date: Sep 29, 2017
• Actual Primary Completion Date: Sep 23, 2020
• Anticipated Study Completion Date: Sep 28, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 18F-DOPA PET Patients will receive 18FDOPA-PET for radiation treatment planning

Drug: Fluorine F 18 Fluorodopa; Contrast used in PET; Other Names: 18F- FDOPA 3,4-dihydroxy-6-[18F] fluoro-L-phenylalanine ; 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; Other Names: IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy ; Procedure: Positron Emission Tomography; imaging test; Other Names: PET PET SCAN Positron Emission Tomography Scan Positron-Emission Tomography

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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)

3. 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.

4. Re-operative Count [up to 2 years]

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

5. 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'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Nadia N Laack, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 22, 2019

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03242824
• Other Study ID Numbers: 16-006072; MC167B; NCI-2017-02479
• First Posted: Aug 8, 2017
• Last Update Posted: Jul 5, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glioma

Study Results

Participant Flow

Pre-assignment Detail	1 registered patient did not proceed to protocol treatment because they were deemed ineligible.

Arm/Group Title	18F-DOPA PET
Arm/Group Description	Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. 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. Positron Emission Tomography: imaging test
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	18F-DOPA PET
Arm/Group Description	Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. 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. Positron Emission Tomography: imaging test
Overall Participants	20
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	53
Sex: Female, Male (Count of Participants)
Female	5 25%
Male	15 75%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	20 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	19 95%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-DOPA PET
Arm/Group Description	Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. 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. Positron Emission Tomography: imaging test
Measure Participants	20
Number (95% Confidence Interval) [Proportion of participants]	0.85 4.3%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-DOPA PET
Arm/Group Description	Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. 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. Positron Emission Tomography: imaging test
Measure Participants	20
Median (95% Confidence Interval) [years]	3.7

3. Secondary Outcome

Title	Toxicity, Rate of Grade 3 or Higher Treatment Related to Toxicities
Description	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)
Time Frame	up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-DOPA PET
Arm/Group Description	Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. 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. Positron Emission Tomography: imaging test
Measure Participants	20
Number [percentage of participants]	40 200%

4. Secondary Outcome

Title	Quality of Life Brief Fatigue Index (BFI) Change From Baseline
Description	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.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

All patients that entered a baseline and at 3 months.

Arm/Group Title	18F-DOPA PET
Arm/Group Description	Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. 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. Positron Emission Tomography: imaging test
Measure Participants	19
Median (95% Confidence Interval) [score on a scale]	0.28

5. Secondary Outcome

Title	Re-operative Count
Description	Count of patients that receive re-operation post re-irradiation
Time Frame	up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-DOPA PET
Arm/Group Description	Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. 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. Positron Emission Tomography: imaging test
Measure Participants	20
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	Quality of Life MDASI-BT Change From Baseline
Description	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'.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

All treated patients that had available data at baseline and during end of treatment.

Arm/Group Title	18F-DOPA PET
Arm/Group Description	Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. 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. Positron Emission Tomography: imaging test
Measure Participants	19
Median (95% Confidence Interval) [score on a scale]	-0.15

Adverse Events

Time Frame	up to 2 years from randomization
Adverse Event Reporting Description	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)
Arm/Group Title	18F-DOPA PET
Arm/Group Description	Patients will receive 18FDOPA-PET for radiation treatment planning. Fluorine F 18 Fluorodopa: Contrast used in PET. 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. Positron Emission Tomography: imaging test
All Cause Mortality
	18F-DOPA PET
	Affected / at Risk (%)	# Events
Total	15/20 (75%)
Serious Adverse Events
	18F-DOPA PET
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	18F-DOPA PET
	Affected / at Risk (%)	# Events
Total	20/20 (100%)
Endocrine disorders
Endocrine disorders - Other, specify	1/20 (5%)	1
Eye disorders
Blurred vision	1/20 (5%)	4
Eye disorders - Other, specify	1/20 (5%)	1
Optic nerve disorder	2/20 (10%)	5
Gastrointestinal disorders
Dysphagia	1/20 (5%)	1
Nausea	2/20 (10%)	3
General disorders
Fatigue	17/20 (85%)	49
Infections and infestations
Urinary tract infection	1/20 (5%)	1
Injury, poisoning and procedural complications
Dermatitis radiation	1/20 (5%)	1
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb	1/20 (5%)	1
Nervous system disorders
Central nervous system necrosis	7/20 (35%)	14
Cognitive disturbance	12/20 (60%)	23
Dysphasia	1/20 (5%)	1
Headache	4/20 (20%)	6
Memory impairment	8/20 (40%)	11
Muscle weakness left-sided	1/20 (5%)	1
Muscle weakness right-sided	3/20 (15%)	3
Seizure	6/20 (30%)	8
Skin and subcutaneous tissue disorders
Alopecia	5/20 (25%)	6
Vascular disorders
Hypertension	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.