Non-invasive Glioma Characterization Through Molecular Imaging

NCT ID: NCT03684109

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glioma Brain Tumor Primary Brain Tumor Malignant Glioma Malignant Primary Brain Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

3T MRI Scanner

Intervention Type DEVICE

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

Interventions

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3T MRI Scanner

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

Intervention Type DEVICE

Other Intervention Names

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3 Tesla (3T) Magnetic Resonance Imaging Scanner

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Macarena De La Fuente, MD

Assistance Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Macarena De La Fuente, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nathalie Padron

Role: CONTACT

305-243-3530

Facility Contacts

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Nathalie Padron

Role: primary

305-243-3530

Other Identifiers

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20180606

Identifier Type: -

Identifier Source: org_study_id

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