FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas | NCT02371031

NCT02371031

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: FDOPA-PET/MRI	Experimental	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.	Drug: 6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine Device: PET/MRI Procedure: Surgical resection (standard of care)

Name	Type	Description	Arm Group Labels	Other Names
6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine	Drug		Arm 1: FDOPA-PET/MRI	Fluorodopa FDOPA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of cases in which the addition of FDOPA-PET to MRI changes the surgical plan	We will consider our primary endpoint successful if FDOPA-PET changes the surgical plan in at least 4 of the 20 patients (20%), a much lower margin than previously reported with [C-11]methionine which is on the order of 60-70% of cases. When safe and feasible, these discrepant areas identified on FDOPA-PET/MRI will undergo tissue sampling. However, tissue sampling of discrepant areas may not be possible in all patients, and this decision will be made by the treating neurosurgeon.	At the time of surgery (approximately week 2)

Eligibility Module

Eligibility Criteria

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.

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

ID	Term
C043437	fluorodopa F 18
D059039	Standard of Care

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation