FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas

The Washington University

Status and phase: Terminated; Phase 1

Conditions: Glioma; Malignant Glioma

Treatments: Drug: 6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine; Device: PET/MRI; Procedure: Surgical resection (standard of care)

Study type: Interventional

Funder types: Other

Identifiers

NCT02371031

201502019

Details and patient eligibility

About

This is a pilot study designed to evaluate the potential of using FDOPA-PET/MRI for improving surgical planning and providing non-invasive prognostic information in patients with gliomas that have substantial non-enhancing regions. The results will be used to develop larger adequately powered studies.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Known or suspected diagnosis of intracranial glioma with substantial non-enhancing regions as assessed by contrast enhanced MRI. For the purposes of this study, gliomas with substantial non-enhancing regions are defined as having contrast-enhancing volumes of less than 50% of the total estimated tumor volume. Gliomas that do not have any contrast-enhancing regions are eligible for this study.
• 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

• Patients undergoing PET/MRI: contraindication to gadolinium contrast enhanced brain MRI (i.e., allergy to gadolinium contrast, MRI-incompatible implantable devices, GFR < 30 mL/min/1.73, and severe claustrophobia). At the discretion of the responsible physician, FDOPA-PET/CT may be performed if PET/MRI is contraindicated or unavailable. If FDOPA-PET/CT is performed, the patient must have undergone a contrast-enhanced MRI for fusion with FDOPA-PET no more than 4 weeks before the FDOPA-PET/CT.
• 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Arm 1: FDOPA-PET/MRI

Experimental group

Description:

* 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.

Treatment:

Device: PET/MRI

Procedure: Surgical resection (standard of care)

Drug: 6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine