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18F-DOPA-PET Scan for Brain Tumor
Phase < 1
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
Ability to provide tissue for mandatory correlative research component
Planned craniotomy and resection or biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial uses a new imaging procedure, 18F-DOPA-PET scan, to help find and plan surgery for gliomas.
Who is the study for?
This trial is for patients with new or returning gliomas who can undergo MRI scans and surgery. They must be willing to provide tissue samples, sign a release for medical records, and use contraception if of childbearing potential. It's not suitable for those unable to have MRI with contrast, nursing women, pregnant women, or individuals on certain dopamine-related medications.Check my eligibility
What is being tested?
The study tests the effectiveness of using an imaging procedure called 18F-DOPA-PET in planning surgeries for glioma patients. This involves comparing traditional methods like biopsy and CT scans with this advanced PET scan technique to see if it improves surgical outcomes.See study design
What are the potential side effects?
While the trial focuses on imaging techniques rather than drugs, side effects may include discomfort from the biopsy procedure, reactions to contrast agents used in MRI and PET scans such as mild allergic reactions or kidney issues in susceptible individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a tissue sample for research.
Select...
I am scheduled for brain surgery to remove or sample a tumor.
Select...
My MRI shows I have a new or returning brain tumor.
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
Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N
Secondary outcome measures
Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI
Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue
MRI contrast enhancement values
+2 moreOther outcome measures
Accurate identification of the highest grade/highest density disease
Accurate identification of tumor extent
Role of metabolic imaging in neurosurgical resection planning
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (18F-DOPA-PET)Experimental Treatment8 Interventions
Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/CT scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diffusion Weighted Imaging
2006
Completed Phase 2
~150
Biopsy
2014
Completed Phase 4
~850
Computed Tomography
2017
Completed Phase 2
~2720
Fluorine F 18 Fluorodopa
2017
Completed Phase 2
~30
Positron Emission Tomography
2008
Completed Phase 2
~2240
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Perfusion Magnetic Resonance Imaging
2008
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,712 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,081 Total Patients Enrolled
Nadia LaackPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide a tissue sample for research.I cannot have MRI scans with contrast due to a condition like a pacemaker or kidney failure.I cannot have a specific brain scan due to my medication or condition.I am of childbearing age and do not plan to use birth control.I am scheduled for brain surgery to remove or sample a tumor.My MRI shows I have a new or returning brain tumor.I am currently breastfeeding.I have given my written consent, or if under 18, my guardian has consented.I am willing to allow my radiation and follow-up records to be shared.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (18F-DOPA-PET)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open spots left in this clinical trial?
"Per the information available on clinicaltrials.gov, this specific medical study is no longer recruiting patients; it was first made visible to the public on January 22nd 2014 and last updated October 7th 2022. Despite being closed for recruitment, there are currently 708 other trials that require participants right now."
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