Non-invasive Glioma Characterization Through Molecular Imaging

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT03684109
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
47.2
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Device: 3T MRI Scanner
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging
Actual Study Start Date :
Jan 25, 2019
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: IDH-Mutant Glioma Patients

Patients who have suspected or confirmed gliomas and are scheduled to undergo biopsy or resection of their brain tumors will receive a 3 Tesla (3T) Magnetic Resonance Imaging (MRI) scan of their brain.

Device: 3T MRI Scanner
3T MRI Scanner providing Mega-laser sequence for single-voxel Magnetic Resonance Spectroscopy (MRS) data for 2 hydroxyglutarate (2HG) quantitation.
Other Names:
  • 3 Tesla (3T) Magnetic Resonance Imaging Scanner
  • Outcome Measures

    Primary Outcome Measures

    1. 2HG Concentration via 3T MRI Scanner [Day 1]

      2HG concentrations as measured via 3T MRI Scanner.

    2. 2HG Concentration from tissue samples [Day 1]

      2HG concentrations as measured via patient's surgically excised tissue sample ex vivo by tissue based liquid chromatography-mass spectrometry (LC-MS)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of MiamiMiamiFloridaUnited States33136

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Macarena De La Fuente, MD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Macarena De La Fuente, MD, Assistance Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT03684109
    Other Study ID Numbers:
    • 20180606
    First Posted:
    Sep 25, 2018
    Last Update Posted:
    Mar 17, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Macarena De La Fuente, MD, Assistance Professor, University of Miami
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 17, 2022