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F-18 Fluorodopa PET Scan for Brain Tumor
Phase < 1
Waitlist Available
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planned craniotomy and resection or biopsy
MRI findings compatible with newly diagnosed high- or low-grade malignant glioma
Must not have
Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
Pregnant women; nursing women; men or women of childbearing potential who are unwilling to employ adequate contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how well fluorine F 18 fluorodopa-labeled PET scan works in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma.
Who is the study for?
This trial is for adults over 18 with a new diagnosis of high or low-grade malignant glioma, who are planning to have brain surgery (craniotomy and resection or biopsy). Participants must be able to provide medical records and consent. Women capable of becoming pregnant must test negative for pregnancy within 48 hours before receiving the study drug.
What is being tested?
The trial studies how well a special PET scan using fluorine F 18 fluorodopa works in planning surgical and radiation treatments for brain tumors. It aims to improve treatment by providing better imaging techniques to guide doctors during these procedures.
What are the potential side effects?
While not directly related to side effects from medications, this trial involves exposure to radiation through PET scans and potential risks associated with magnetic resonance imaging (MRI), surgery, and radiation therapy which can include discomfort, bleeding, infection, or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for brain surgery to remove or sample a tumor.
Select...
My MRI shows I might have a serious brain tumor.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have MRI scans with contrast due to a condition like having a pacemaker or kidney failure.
Select...
I am not pregnant, nursing, or if capable of childbearing, I am willing to use contraception.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
18F- FDOPA-PET metabolic imaging information
18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
Secondary study objectives
18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies
Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies
With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm IExperimental Treatment8 Interventions
Beginning at no more than 1 week before biopsy or resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
biopsy
2002
Completed Phase 4
~8270
therapeutic conventional surgery
2003
Completed Phase 3
~12900
radiation therapy treatment planning/simulation
2009
Completed Phase 1
~50
computed tomography
2010
Completed Phase 2
~1200
positron emission tomography
2010
Completed Phase 2
~1370
radiation therapy
1994
Completed Phase 3
~13390
magnetic resonance imaging
2002
Completed Phase 2
~1820
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,813 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,307 Previous Clinical Trials
2,962,375 Total Patients Enrolled
Nadia N. Laack, M.D.Study ChairMayo Clinic
4 Previous Clinical Trials
182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for brain surgery to remove or sample a tumor.My kidney function is low but I can still join the study without contrast for the pMRI.I cannot have MRI scans with contrast due to a condition like having a pacemaker or kidney failure.My MRI shows I might have a serious brain tumor.I cannot have an 18F-FDOPA PET scan due to Parkinson's or related medication.I am not pregnant, nursing, or if capable of childbearing, I am willing to use contraception.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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