Ignite Creation Date:
2024-05-06 @ 2:19 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04286386
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2020-02-24
Brief Title:
Development and Evaluation of a Quantitative HP MRI for Clinical Prostate Cancer Exam
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Development Amp Evaluation of a Quantitative HP MRI Clinical Prostate Cancer Exam
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 examines if a prostate magnetic resonance spectroscopic imaging can be performed on a 3T scanner using an investigational contrast called hyperpolarized 13-C pyruvate for the development of a clinical prostate cancer exam 3T refers to the strength of the magnetic resonance spectroscopic imaging MRSI machine MRSI is a magnetic resonance imaging MRI technique that can show certain chemical differences in healthy and diseased prostate tumor tissue compared to standard multiparametric MRI that may not detect the tumor Hyperpolarized HP 13-C pyruvate is a contrast drug that may help the scanner see the tumor site better during imaging Hyperpolarization of 13-C pyruvate may allow pyruvate and its metabolites to be detected upon injection which in turn allow the prostate cancer to be found and treated
Detailed Description:
PRIMARY OBJECTIVES
I To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging MRSI including kpl which assesses the rate of conversion of 13-C pyruvate to 13-C lactate in the tissue of interest using a test-retest study design
II To test the reproducibility of the normalized area under the lactate curve nLac a semi-quantitative biomarker for tumor metabolism
SECONDARY OBJECTIVES
I To provide initial assessment of the sensitivity and specificity of hyperpolarized 13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer
II To assess the correlation between kpl and tumor grade
OUTLINE Patients are assigned to 1 of 3 arms
ARM Ia Patients receive hyperpolarized carbon C 13 pyruvate intravenously IV and undergo MRSI at least 5 weeks after prostate cancer biopsy
ARM Ib Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after
ARM II Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy followed by standard of care surgery within 6 months after
After the completion of study patients in Arm Ia and Arm Ib are followed up once
I To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging MRSI including kpl which assesses the rate of conversion of 13-C pyruvate to 13-C lactate in the tissue of interest using a test-retest study design
II To test the reproducibility of the normalized area under the lactate curve nLac a semi-quantitative biomarker for tumor metabolism
SECONDARY OBJECTIVES
I To provide initial assessment of the sensitivity and specificity of hyperpolarized 13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer
II To assess the correlation between kpl and tumor grade
OUTLINE Patients are assigned to 1 of 3 arms
ARM Ia Patients receive hyperpolarized carbon C 13 pyruvate intravenously IV and undergo MRSI at least 5 weeks after prostate cancer biopsy
ARM Ib Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after
ARM II Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy followed by standard of care surgery within 6 months after
After the completion of study patients in Arm Ia and Arm Ib are followed up once
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA211150 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchR01CA211150 |
| NCI-2020-00746 | REGISTRY | None | None |
| 2018-1164 | OTHER | None | None |