Brain Tumor Adult Clinical Trial
Official title:
Investigating Metabolic Characteristics of Intracranial Malignancy In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04390906 -
A Study of Cognitive Changes in Patients Receiving Brain Radiation
|
||
| Recruiting |
NCT05298995 -
GD2-CAR T Cells for Pediatric Brain Tumours
|
Phase 1 | |
| Completed |
NCT02599142 -
Comparing Immobilisation Shells in Cranial Radiotherapy
|
N/A | |
| Not yet recruiting |
NCT04113278 -
Role of Fibirnogen Like Protein 2 as Aprognostic Factor in High Grade Glioma
|
||
| Enrolling by invitation |
NCT06391294 -
Neuronal and Network Mechanisms of Electrocortical Stimulation
|
||
| Active, not recruiting |
NCT05832450 -
Predictive Model to Calculate the Risk of RBC Transfusion in Elective Brain Tumours Resections (TScoreBTR)
|
||
| Recruiting |
NCT03213002 -
Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04468919 -
Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation Toolkit
|
N/A | |
| Recruiting |
NCT04742231 -
Handheld Dynamometer During Awake Craniotomy Pilot
|
N/A | |
| Recruiting |
NCT04725032 -
Effects of Intravenous Anesthesia and Balanced Anesthesia on Flash Visual Evoked Potentials
|
N/A | |
| Recruiting |
NCT03542409 -
Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas
|
N/A | |
| Active, not recruiting |
NCT04165941 -
Novel Gamma-Delta (γδ)T Cell Therapy for Treatment of Patients With Newly Diagnosed Glioblastoma
|
Phase 1 | |
| Completed |
NCT03731455 -
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring
|
N/A | |
| Suspended |
NCT05169944 -
Magrolimab in Children and Adults With Recurrent or Progressive Malignant Brain Tumors
|
Phase 1 |