Clinical Trial: Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Investigating Metabolic Characteristics of Intracranial Malignancy In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)

Brief Summary: This is a non-randomized, purely observational, feasibility study to detect metabolic changes in patients with brain malignancy using a novel hyperpolarized [1-13C]pyruvate MRSI.

Detailed Summary:

The aim of this pilot study is to test the hypothesis that patients with brain malignancy present altered [1-13C]lactate and 13C-bicarbonate production from infused hyperpolarized [1-13C]pyruvate in tumor as compared to in normal-appearing brain regions. To achieve this aim investigators will assess metabolic phenotype in cancer patients with brain tumors (n = 8) and in healthy control subjects (n = 8). Total target enrollment will be set at 25 subjects to allow for attrition and screen failures.

During each imaging session, following localization of the tumor in brain, tissue characteristics and morphological changes will be evaluated with 1H MRI. Then, cerebral metabolism will be assessed utilizing 13C MRSI after an intravenous injection with hyperpolarized [1-13C]pyruvate. Finally, contrast-enhanced 1H MRI will be acquired. The study agent, hyperpolarized [1-13C]pyruvate, will be administered under a Food and Drug Administration (FDA) Investigational New Drug (IND), which was approved on 1/3/2017 (IND# 133229).

Preliminary data in human are essential to secure larger scale funding required for clinical studies. The investigators believe the ability to measure such metabolic shifts in vivo could have major significance in assessing the efficacy of multiple anti-tumor therapies currently under development that target reversing the Warburg effect as a means of controlling tumor growth. Brain tumor applications at the Advanced Imaging Research Center, Harold C. Simmons Comprehensive Cancer Center and the Neuro-Oncology Program of the Development of Neurological Surgery at the UT Southwestern Medical Center offer today a unique opportunity to lead globally the translational scientific efforts in this field.


Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: 13C-pyruvate Metabolic Product Ratio [ Time Frame: Screening (Baseline) and 1 day of Study Visit ]

Measurement of the ratio of metabolic products, [1-13C]lactate and 13C-bicarbonate, from hyperpolarized [1-13C]pyruvate will be used as an index of metabolic balance between glycolytic pathway and mitochondrial oxidative phosphorylation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: February 16, 2017
Date Started: May 1, 2017
Date Completion: April 30, 2018
Last Updated: February 23, 2017
Last Verified: February 2017