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Non-invasive Glioma Characterization Through Molecular Imaging

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ClinicalTrials.gov Identifier: NCT03684109
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Macarena De La Fuente, University of Miami

Brief Summary:
MRI-based sequences can provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Condition or disease Intervention/treatment Phase
Glioma Brain Tumor Primary Brain Tumor Malignant Glioma Malignant Primary Brain Tumor Diagnostic Test: 3T MRI Scanner Not Applicable

Detailed Description:
This is a pilot study aiming at developing and optimizing MRI-based sequences to provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2HG) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IDH-Mutant Glioma Patients
MRI-based sequence data for 2HG quantification acquired from the image of the brain via 3T MRI scanner.
Diagnostic Test: 3T MRI Scanner
3T MRI image of the brain at Baseline, prior to standard-of-care surgery.
Other Name: 3 Tesla (3T) Magnetic Resonance Imaging Scanner




Primary Outcome Measures :
  1. Measurement and Comparison of in vivo vs. ex-vivo 2HG Concentration IDH-Mutant Glioma [ Time Frame: Up to 10 months ]
    The primary objective is to measure and compare 2HG concentrations as measured in vivo via 3T MRI Scanner, and directly measured in the patient's surgically excised tissue sample ex vivo by tissue-based liquid chromatography-mass spectrometry (LC-MS). The primary endpoint is 2HG concentration measurement.


Secondary Outcome Measures :
  1. Calculation and Correlation of Cellularity Index in IDH-Mutant Glioma [ Time Frame: Up to 10 months ]
    Calculation of the cellularity index in IDH-mutant glioma in pre-surgical cases in vivo using MRI-based sequence data via 3T MRI Scanner, and the correlation of this index to formalin fixed paraffin embedded (FFPE) analysis. Samples will be described as low-moderate cellularity or high cellularity by a neuro-pathologist. Tumors of low cellularity will be characterized by the distribution of neoplastic cells singly within infiltrated brain and separated by abundant native neuroparenchyma, whereas cases designated as highly cellular are those that exhibit crowded or confluent tumor cell arrangements with scant, if any, intervening neuropil.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (≥18 year old)
  • Subjects with suspected or confirmed gliomas and who will have a medically indicated biopsy or resection of his/her brain lesion.

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Patients unable to have MRI done

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684109


Locations
United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Macarena De la Fuente, MD    305-243-4951    mdelafuente@miami.edu   
Principal Investigator: Macarena De La Fuente, MD         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Macarena De La Fuente, MD University of Miami

Responsible Party: Macarena De La Fuente, Assistance Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03684109     History of Changes
Other Study ID Numbers: 20180606
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Macarena De La Fuente, University of Miami:
Glioma
Brain Tumor
Primary Brain Tumor
Malignant Primary Brain Tumor
Malignant Glioma
Non-invasive glioma characterization
Molecular Imaging
Isocitrate Dehydrogenase (IDH) Mutations
MRI-Based Sequencing

Additional relevant MeSH terms:
Neoplasms
Glioma
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
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