Non-invasive Glioma Characterization Through Molecular Imaging

• Sponsor: University of Miami (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03684109
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 47.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma; Brain Tumor; Primary Brain Tumor; Malignant Glioma; Malignant Primary Brain Tumor	Device: 3T MRI Scanner	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging
• Actual Study Start Date: Jan 25, 2019
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: 3T MRI Scanner; 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

Outcome Measures

Primary Outcome Measures

1. 2HG Concentration via 3T MRI Scanner [Day 1]

   2HG concentrations as measured via 3T MRI Scanner.

2. 2HG Concentration from tissue samples [Day 1]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Macarena De La Fuente, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Macarena De La Fuente, MD, Assistance Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03684109
• Other Study ID Numbers: 20180606
• First Posted: Sep 25, 2018
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Macarena De La Fuente, MD, Assistance Professor, University of Miami: Non-invasive glioma characterization; Molecular Imaging; Isocitrate Dehydrogenase (IDH) Mutations; MRI-Based Sequencing
• Additional relevant MeSH terms: Glioma; Brain Neoplasms

Study Results

No Results Posted as of Mar 17, 2022