Back to resultsFDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas
Primary Purpose
Glioma, Malignant Glioma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine
PET/MRI
Surgical resection (standard of care)
Sponsored by
About this trial
This is an interventional diagnostic trial for Glioma
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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1: FDOPA-PET/MRI
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02371031
First Posted
February 9, 2015
Last Updated
November 29, 2016
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02371031
Brief Title
FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas
Official Title
FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Funding source for study ended.
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Malignant Glioma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: FDOPA-PET/MRI
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine
Other Intervention Name(s)
Fluorodopa, FDOPA
Intervention Type
Device
Intervention Name(s)
PET/MRI
Intervention Type
Procedure
Intervention Name(s)
Surgical resection (standard of care)
Primary Outcome Measure Information:
Title
Percentage of cases in which the addition of FDOPA-PET to MRI changes the surgical plan
Description
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.
Time Frame
At the time of surgery (approximately week 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammie Benzinger, M.D., Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas
We'll reach out to this number within 24 hrs