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NCT03684109 Clinical Trial

Non-invasive Glioma Characterization Through Molecular Imaging

Glioma Clinical Trial

Official title:
Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03684109
Other study ID # 20180606
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 25, 2019
Est. completion date January 2025

Study information
Verified date January 2024
Source University of Miami
Contact Nathalie Padron
Phone 305-243-3530
Email npadron@med.miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 2HG Concentration via 3T MRI Scanner 2HG concentrations as measured via 3T MRI Scanner. Day 1
Primary 2HG Concentration from tissue samples 2HG concentrations as measured via patient's surgically excised tissue sample ex vivo by tissue based liquid chromatography-mass spectrometry (LC-MS) Day 1
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