Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT03830151
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2019-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI) scan may help researchers better diagnose glioma in patients with brain tumors.
Detailed Description:
PRIMARY OBJECTIVES:
I. To establish a clinical infrastructure for performing hyperpolarized carbon C 13 pyruvate (hyperpolarized 13-C-pyruvate) imaging in the human brain at MD Anderson.
SECONDARY OBJECTIVES:
I. To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate (kpl) values and Ki-67 quantitation in the tumor.
II. To compare kpl values between tumor and normal brain within patient. III. To assess the association between kpl values and pathology results, including conventional, diffusion, perfusion, and permeability imaging.
IV. To assess the association between kpl values and magnetic resonance (MR) imaging findings.
V. To assess the association between kpl values and genomic findings, including methylation, ribonucleic acid \[RNA\], and deoxyribonucleic acid \[DNA\]).
OUTLINE:
Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds and then undergo an MRSI scan.
After completion of study, patients are followed up for 1 day.
I. To establish a clinical infrastructure for performing hyperpolarized carbon C 13 pyruvate (hyperpolarized 13-C-pyruvate) imaging in the human brain at MD Anderson.
SECONDARY OBJECTIVES:
I. To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate (kpl) values and Ki-67 quantitation in the tumor.
II. To compare kpl values between tumor and normal brain within patient. III. To assess the association between kpl values and pathology results, including conventional, diffusion, perfusion, and permeability imaging.
IV. To assess the association between kpl values and magnetic resonance (MR) imaging findings.
V. To assess the association between kpl values and genomic findings, including methylation, ribonucleic acid \[RNA\], and deoxyribonucleic acid \[DNA\]).
OUTLINE:
Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds and then undergo an MRSI scan.
After completion of study, patients are followed up for 1 day.
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?:
None
Is an FDA AA801 Violation?: