FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas
NCT ID: NCT02371031
Last Updated: 2016-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
11 participants
INTERVENTIONAL
2015-03-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Arm 1: FDOPA-PET/MRI
* Patients with known or suspected brain gliomas that are non-enhancing or have substantial non-enhancing regions will undergo FDOPA-PET/MRI within 2 weeks prior to planned standard of care surgical resection and/or stereotactic biopsy. In the same planning session, the MRI alone will be reviewed and then the FDOPA-PET data will be added to the planning.
* In the event that a patient cannot undergo MRI or PET/MRI is not available (e.g. due to maintenance), FDOPA-PET/CT can be performed instead at the discretion of the responsible physician.
* When feasible and at the discretion of the neurosurgeon performing the resection, areas of suspected tumor identified on the FDOPA-PET/MRI study but not the MRI alone will undergo tissue sampling.
6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine
PET/MRI
Surgical resection (standard of care)
Interventions
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6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine
PET/MRI
Surgical resection (standard of care)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Standard of care surgical resection and/or stereotactic biopsy of the brain tumor planned within 2 weeks of the FDOPA-PET/MRI study.
* At least 18 years of age.
* Measurable disease on MRI defined as tumor measuring at least 1 cm in two perpendicular dimensions.
* Karnofsky performance of \> 50 corresponding to ECOG categories 0, 1, or 2. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 30 mL/min/1.73 m\^2
* Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria
* Prior chemotherapy or radiation therapy for the brain tumor. Prior biopsy or surgical resection of the glioma without additional therapy is not an exclusion criterion.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine or serum pregnancy test no more than 3 days prior to FDOPA injection.
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Tammie Benzinger, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201502019
Identifier Type: -
Identifier Source: org_study_id