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

November 29, 2016 updated by: Washington University School of Medicine
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: PET/MRI
Drug: 6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine
Other Names:
  • Fluorodopa
  • FDOPA
Procedure: Surgical resection (standard of care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of cases in which the addition of FDOPA-PET to MRI changes the surgical plan
Time Frame: At the time of surgery (approximately week 2)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Tammie Benzinger, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201502019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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