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18F-DOPA-PET Scan for Brain Tumor
Phase 2
Waitlist Available
Led By Nadia Laack
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed newly diagnosed grade IV malignant glioma (Note: grade III patients are no longer being enrolled)
Be older than 18 years old
Must not have
Patients diagnosed with anaplastic oligodendroglioma
Men or women of childbearing potential who are unwilling to employ adequate contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial studies how well a special brain scan can find tumors in patients with recent brain tumor diagnoses undergoing radiation therapy. The goal is to help doctors predict treatment response and plan the best treatment.
Who is the study for?
This trial is for adults with a new diagnosis of grade IV malignant glioma who can give consent, complete questionnaires, and undergo all required imaging at Mayo Clinic locations. It's not for those with anaplastic oligodendroglioma, unable to have MRI with contrast, pregnant or nursing women, or those not using birth control.
What is being tested?
The study tests how well 18F-DOPA-PET scans identify tumors in patients receiving radiation therapy for newly diagnosed gliomas. The goal is to see if these scans before and during treatment can predict outcomes and guide therapy planning.
What are the potential side effects?
Potential side effects are related to the PET scan procedure which may include discomfort from lying still during the scan. Temozolomide chemotherapy could cause nausea, fatigue, hair loss among others. Radiation therapy might lead to skin irritation or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis is a grade IV malignant brain tumor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with anaplastic oligodendroglioma.
Select...
I am of childbearing age and do not plan to use birth control.
Select...
I am currently breastfeeding.
Select...
I cannot have MRI scans with contrast due to a condition like having a pacemaker.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Grade IV MGMT Un-methylated Patients That Experience Confirmed-progression-free Survival at 6 Months (CPFS6)
Secondary outcome measures
Overall Survival
Progression Free Survival
Quality of Life Evaluated With the MD Anderson Symptom Inventory Brain Tumor Module and Mini-Mental Status Exam Questionnaires
+2 moreOther outcome measures
Inter-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation
Intra-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation
Magnetic Resonance Imaging-only Defined Volumes and the Volumes Defined With the Combination of Magnetic Resonance and Positron Emission Tomography Planning
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)Experimental Treatment7 Interventions
Patients undergo 18F DOPA-PET, pMRI and DTI within 14 days before radiation therapy, 3-6 weeks after radiation therapy, and during follow-up. Patients also undergo IMRT over 30 fractions and receive temozolomide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perfusion Magnetic Resonance Imaging
2008
Completed Phase 2
~50
Positron Emission Tomography
2008
Completed Phase 2
~2210
Temozolomide
2010
Completed Phase 3
~1930
Diffusion Weighted Imaging
2006
Completed Phase 2
~150
Fluorine F 18 Fluorodopa
2017
Completed Phase 2
~30
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Malignant Glioma include radiation therapy and advanced imaging techniques like PET scans. Radiation therapy targets and damages the DNA of cancer cells, preventing them from replicating and causing cell death.
PET imaging, using tracers like Fluorine F 18 Fluorodopa (18F-DOPA), detects tumors by highlighting areas with increased amino acid metabolism, which is typically higher in malignant cells. This precise detection is crucial for accurately targeting radiation therapy, thereby improving treatment planning and potentially leading to better outcomes for patients with Malignant Glioma.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,315 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,310 Total Patients Enrolled
Nadia LaackPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
92 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- All my imaging and planning for radiation therapy will be done at Mayo Clinic Rochester.I cannot have a specific brain scan due to my medication or condition.I cannot have MRI scans with contrast due to a condition like having a pacemaker.I have been diagnosed with anaplastic oligodendroglioma.My diagnosis is a grade IV malignant brain tumor.I am of childbearing age and do not plan to use birth control.I am currently breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)
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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