search
Back to results

Non-invasive Glioma Characterization Through Molecular Imaging

Primary Purpose

Glioma, Brain Tumor, Primary Brain Tumor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3T MRI Scanner
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma focused on measuring Non-invasive glioma characterization, Molecular Imaging, Isocitrate Dehydrogenase (IDH) Mutations, MRI-Based Sequencing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IDH-Mutant Glioma Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

2HG Concentration via 3T MRI Scanner
2HG concentrations as measured via 3T MRI Scanner.
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)

Secondary Outcome Measures

Full Information

First Posted
September 21, 2018
Last Updated
January 3, 2023
Sponsor
University of Miami
search

1. Study Identification

Unique Protocol Identification Number
NCT03684109
Brief Title
Non-invasive Glioma Characterization Through Molecular Imaging
Official Title
Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Brain Tumor, Primary Brain Tumor, Malignant Glioma, Malignant Primary Brain Tumor
Keywords
Non-invasive glioma characterization, Molecular Imaging, Isocitrate Dehydrogenase (IDH) Mutations, MRI-Based Sequencing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IDH-Mutant Glioma Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
3T MRI Scanner
Other Intervention Name(s)
3 Tesla (3T) Magnetic Resonance Imaging Scanner
Intervention Description
3T MRI Scanner providing Mega-laser sequence for single-voxel Magnetic Resonance Spectroscopy (MRS) data for 2 hydroxyglutarate (2HG) quantitation.
Primary Outcome Measure Information:
Title
2HG Concentration via 3T MRI Scanner
Description
2HG concentrations as measured via 3T MRI Scanner.
Time Frame
Day 1
Title
2HG Concentration from tissue samples
Description
2HG concentrations as measured via patient's surgically excised tissue sample ex vivo by tissue based liquid chromatography-mass spectrometry (LC-MS)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie Padron
Phone
305-243-3530
Email
npadron@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Macarena De La Fuente, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Padron
Phone
305-243-3530
Email
npadron@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Macarena De La Fuente, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Non-invasive Glioma Characterization Through Molecular Imaging

We'll reach out to this number within 24 hrs