Clinical Trial Details
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NCT02371031 : FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas
PhasePhase 0
AgesMin: 18 Years Max: N/A
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

- 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.
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