18F-DOPA-PET in Planning Surgery in Patients With Gliomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Mayo Clinic
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02020720
First received: December 19, 2013
Last updated: April 18, 2016
Last verified: January 2016
  Purpose
This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.

Condition Intervention
Malignant Glioma
Recurrent Brain Neoplasm
Procedure: Biopsy
Procedure: Computed Tomography
Procedure: Diffusion Weighted Imaging
Drug: Fluorine F 18 Fluorodopa
Other: Laboratory Biomarker Analysis
Procedure: Perfusion Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Procedure: Therapeutic Conventional Surgery

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluating the Impact of 18F-DOPA-PET on Neurosurgical Planning for Gliomas

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    To determine the optimal PET threshold for distinguishing HGG from LGG brain tissue, receiver operating characteristic (ROC) analysis and the Youden's index (sum of the sensitivity and specificity - 1) will be used. The Youden's index will be calculated for each possible T/N threshold. The final ROC area under the curve (AUC) value and confidence intervals will be estimated using ROC analysis methods for clustered continuous data as described by Obychowski.


Secondary Outcome Measures:
  • Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between volumes.

  • Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The relationship between these T/N values, MRI contrast enhancement values, and the histologic grade of the specimen (HGG, LGG, or non-malignant brain tissue) will be determined using multivariate linear regression. These models will also include as appropriate the specimen cellularity and necrosis values.

  • MRI contrast enhancement values [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The relationship between these T/N values, MRI contrast enhancement values, and the histologic grade of the specimen (HGG, LGG, or non-malignant brain tissue) will be determined using multivariate linear regression. These models will also include as appropriate the specimen cellularity and necrosis values.

  • Progression free survival [ Time Frame: The time from study entry to progression, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Proportion of patients whose maximum 18F-DOPA uptake samples are in agreement with the final diagnostic grade [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Associated confidence intervals will be estimated based on dividing the number of patients whose samples agree by the total number of patients.


Other Outcome Measures:
  • Accurate identification of the highest grade/highest density disease [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Paired t-test statistical analysis will be used to evaluate differences in volumes identified using biopsy-validated thresholds as highly aggressive disease comparing 18F-DOPA uptake and relative cerebral blood volume from pMRI.

  • Accurate identification of tumor extent [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Paired t-test statistical analysis will be used to evaluate differences in volumes identified using biopsy-validated thresholds as disease extent comparing 18F-DOPA PET and diffusion maps from DTI.

  • Role of metabolic imaging in neurosurgical resection planning [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Paired t-test analysis will be performed to determine the level of statistical significance between conventional MRI only and PET + MRI volumes.


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (18F-DOPA-PET)
Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/CT scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.
Procedure: Biopsy
Undergo image-guided biopsy
Other Name: Bx
Procedure: Computed Tomography
Undergo 18F-DOPA-PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
Procedure: Diffusion Weighted Imaging
Undergo DTI
Other Names:
  • Diffusion Weighted MRI
  • Diffusion-Weighted Magnetic Resonance Imaging
  • Diffusion-Weighted MR Imaging
  • Diffusion-Weighted MRI
  • DWI
  • DWI MRI
  • DWI-MRI
  • MR Diffusion-Weighted Imaging
Drug: Fluorine F 18 Fluorodopa
Undergo 18F-DOPA-PET/CT
Other Name: 18F-FDOPA
Other: Laboratory Biomarker Analysis
Correlative studies
Procedure: Perfusion Magnetic Resonance Imaging
Undergo pMRI
Other Name: magnetic resonance perfusion imaging
Procedure: Positron Emission Tomography
Undergo 18F-DOPA-PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Procedure: Therapeutic Conventional Surgery
Undergo stereotactic craniotomy

Detailed Description:

PRIMARY OBJECTIVES:

I. Accurately define a standardized 18F-DOPA PET tumor/normal tissue (T/N) threshold to delineate high grade gliomas (HGG) from low grade gliomas (LGG).

SECONDARY OBJECTIVES:

I. Determine correlation between 18F-DOPA PET activity, magnetic resonance imaging (MRI) contrast enhancement and high- or low-grade glioma biopsies.

II. Compare grade from maximum 18F-DOPA uptake samples for all resection patients against the final diagnostic grade, based on the highest grade component from all stereotactic and non-stereotactic samples acquired for open resection patients.

III. Compare volume differences between 18F-DOPA PET activity, MRI contrast enhancement, perfusion MRI (pMRI), and diffusion tensor imaging (DTI) for neurosurgical planning.

IV. Assess the time to progression for patients receiving resections and biopsies only.

TERTIARY OBJECTIVES:

I. Compare histopathology correlations with 18F-DOPA PET against correlations with perfusion MR imaging for accurate identification of the highest grade/highest density disease.

II. Compare histopathology correlations with 18F-DOPA PET against correlations with diffusion tensor imaging information for accurate identification of tumor extent.

III. Compare neurosurgical resection extent volume delineation with and without 18F-FDOPA-PET metabolic imaging information to determine role of metabolic imaging in neurosurgical resection planning.

OUTLINE:

Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/computed tomography (CT) scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.

After completion of study treatment, patients are followed up yearly for 5 years.

  Eligibility

Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MRI findings compatible with newly diagnosed or recurrent high- or low-grade malignant glioma
  • Planned craniotomy and resection or biopsy
  • Willing to sign release of information for any radiation and/or follow-up records
  • Provide informed written consent if >= 18 years; if < 18 years, provide informed written assent and parent or legal guardian provide informed written consent
  • Ability to provide tissue for mandatory correlative research component

Exclusion Criteria:

  • Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
  • Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson's disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists; other potentially interfering drugs consist of: amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline)
  • Any of the following:

    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020720

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Nadia N. Laack         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nadia Laack Mayo Clinic
  More Information

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT02020720     History of Changes
Other Study ID Numbers: MC1373  NCI-2013-02373  MC1373  P30CA015083 
Study First Received: December 19, 2013
Last Updated: April 18, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glioma
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2016