Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT03684109

Conditions

Glioma

Brain Tumor

Primary Brain Tumor

Malignant Glioma

Malignant Primary Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3T MRI Scanner

Study Details

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.

Conditions

Glioma

Brain Tumor

Primary Brain Tumor

Malignant Glioma

Malignant Primary Brain Tumor

Study ID

NCT03684109

Start date

Jan 25, 2019

Status verified date

Feb, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

3T MRI Scanner

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

Primary outcome measure

  • 2HG Concentration via 3T MRI Scanner [ Time Frame: Day 1 ]
  • 2HG Concentration from tissue samples [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Nathalie Padron

305-243-3530npadron@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Nathalie Padron

305-243-3530npadron@med.miami.edu

Principal Investigator:

Macarena De La Fuente, MD

More Information

Sponsor

University of Miami

Last update posted

Apr 20, 2026

Last verified

Feb, 2026

Keywords

  • Non-invasive glioma characterization
  • Molecular Imaging
  • Isocitrate Dehydrogenase (IDH) Mutations
  • MRI-Based Sequencing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-20.