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NCT Number: NCT03684109

Non-invasive Glioma Characterization Through Molecular Imaging

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.

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Key information

Conditions

Glioma Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Malignant Glioma Malignant Primary Brain Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Primary Brain Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Macarena De La Fuente, MD

PRINCIPAL_INVESTIGATOR

Nathalie Padron

CONTACT

[email protected]

305-243-3530

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3T MRI Scanner

Device

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

Primary outcomes

  1. 2HG Concentration via 3T MRI Scanner

    Time frame: Day 1

    2HG concentrations as measured via 3T MRI Scanner.

  2. 2HG Concentration from tissue samples

    Time frame: Day 1

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie Padron

CONTACT

[email protected]

305-243-3530

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2018
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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