NCT03684109

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2019Jan 2027

First Submitted

Initial submission to the registry

September 21, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2019

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

April 20, 2026

Status Verified

February 1, 2026

Enrollment Period

8 years

First QC Date

September 21, 2018

Last Update Submit

April 14, 2026

Conditions

GliomaBrain TumorPrimary Brain TumorMalignant GliomaMalignant Primary Brain Tumor

Keywords

Non-invasive glioma characterizationMolecular ImagingIsocitrate Dehydrogenase (IDH) MutationsMRI-Based Sequencing

Outcome Measures

Primary Outcomes (2)

  • 2HG Concentration via 3T MRI Scanner

    2HG concentrations as measured via 3T MRI Scanner.

    Day 1

  • 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

Study Arms (1)

IDH-Mutant Glioma Patients

EXPERIMENTAL

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

Interventions

3T MRI ScannerDEVICE

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

Also known as: 3 Tesla (3T) Magnetic Resonance Imaging Scanner
IDH-Mutant Glioma Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

GliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Macarena De La Fuente, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Padron

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistance Professor

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 25, 2018

Study Start

January 25, 2019

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

April 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)