Non-invasive Glioma Characterization Through Molecular Imaging
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|ClinicalTrials.gov Identifier: NCT03684109|
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioma Brain Tumor Primary Brain Tumor Malignant Glioma Malignant Primary Brain Tumor||Diagnostic Test: 3T MRI Scanner||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study for Non-invasive Glioma Characterization Through Molecular Imaging|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: IDH-Mutant Glioma Patients
MRI-based sequence data for 2HG quantification acquired from the image of the brain via 3T MRI scanner.
Diagnostic Test: 3T MRI Scanner
3T MRI image of the brain at Baseline, prior to standard-of-care surgery.
Other Name: 3 Tesla (3T) Magnetic Resonance Imaging Scanner
- Measurement and Comparison of in vivo vs. ex-vivo 2HG Concentration IDH-Mutant Glioma [ Time Frame: Up to 10 months ]The primary objective is to measure and compare 2HG concentrations as measured in vivo via 3T MRI Scanner, and directly measured in the patient's surgically excised tissue sample ex vivo by tissue-based liquid chromatography-mass spectrometry (LC-MS). The primary endpoint is 2HG concentration measurement.
- Calculation and Correlation of Cellularity Index in IDH-Mutant Glioma [ Time Frame: Up to 10 months ]Calculation of the cellularity index in IDH-mutant glioma in pre-surgical cases in vivo using MRI-based sequence data via 3T MRI Scanner, and the correlation of this index to formalin fixed paraffin embedded (FFPE) analysis. Samples will be described as low-moderate cellularity or high cellularity by a neuro-pathologist. Tumors of low cellularity will be characterized by the distribution of neoplastic cells singly within infiltrated brain and separated by abundant native neuroparenchyma, whereas cases designated as highly cellular are those that exhibit crowded or confluent tumor cell arrangements with scant, if any, intervening neuropil.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684109
|United States, Florida|
|University of Miami||Not yet recruiting|
|Miami, Florida, United States, 33136|
|Contact: Macarena De la Fuente, MD 305-243-4951 firstname.lastname@example.org|
|Principal Investigator: Macarena De La Fuente, MD|
|Principal Investigator:||Macarena De La Fuente, MD||University of Miami|