Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-28 @ 3:33 AM
Study NCT ID:
NCT03067467
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2017-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Investigating Metabolic Characteristics of Intracranial Malignancy in Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPCIM
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 Description:
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 = 20). Total target enrollment will be set at 25 subjects to account for attrition and screening 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: