Ignite Creation Date:
2024-05-06 @ 2:32 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04346225
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-04-10
Brief Title:
Magnetic Resonance Imaging MRI With Hyperpolarized Pyruvate 13C as Diagnostic Tool in Advanced Prostate Cancer
Sponsor:
Ivan de Kouchkovsky MD
Organization:
University of California San Francisco
Study Overview
Official Title:
Magnetic Resonance MR Imaging With Hyperpolarized Pyruvate 13C as a Diagnostic and Response Monitoring Imaging Tool in Advanced Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging as a diagnostic and response monitoring tool in patients with advanced prostate cancer Preliminary pre-clinical and clinical data demonstrates the ability of HP C-13 pyruvatemetabolic MR imaging to detect high-grade prostate cancer including cancer with neuroendocrine differentiation as well as provide early evidence of metabolic response and resistance following application of systemic therapies for the treatment of advanced prostate cancer patients In the proposed study the investigators aim is to extend the initial clinical results and further develop HP C-13 MRI as an imaging modality in advanced prostate cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the kPL metabolic flux from hyperpolarized HP 1-13Cpyruvate to 1-13Clactate and kPG metabolic flux from HP 2-13Cpyruvate to 5-13Cglutamate within target lesion Cohort A II To determine the mean percent change from baseline in intra-tumoral kPL and kPG within target lesion Cohort B
SECONDARY OBJECTIVE
I To descriptively report on the intra-tumor heterogeneity in kPL and kPG measurement within target lesion Cohorts A and B
EXPLORATORY CORRELATIVE OBJECTIVES
I To determine if the change from baseline in kPL and kPG is associated with subsequent clinical outcomes on treatment including prostate specific antigen PSA response rate and radiographic progression-survival by Prostate Cancer Working Group 3 PCWG3 criteria Cohort B II In target lesions that are measurable by Response Evaluation Criteria in Solid Tumors RECIST 11 criteria to determine whether baseline andor change from baseline in intratumoral kPL and kPG is associated with subsequent objective response by RECIST criteria Cohort B III To determine the mean percent change from baseline in peak intra- tumoral HP lactate lacpyruvate pyr and glutamate glupyr ratios on repeat metabolic magnetic resonance imaging MRI obtained at the time of radiographic disease progression by PCWG3 criteria Cohort B IV To investigate for association between HP kPL and kPG as well as area under the curve AUC lacpyr and glupyr ratios with tissue- based markers of elevated lactate and glutamate metabolism including MYC and Lactate dehydrogenase A LDHA and Pyruvate dehydrogenase PDH protein expression In participants who undergo optional tumor biopsy Cohort A or B V To investigate for an association between HP kPL and kPG as well as area under the curve AUC lacpyr and glupyr ratios with histologic evidence of small cellneuroendocrine differentiation In participants who undergo optional tumor biopsy Cohort A or B
OUTLINE Patients are assigned to 1 of 2 cohorts
COHORT A SINGLE TIME-POINT Patients receive C-1 labeled hyperpolarized carbon C 13 pyruvate intravenously IV over less than 1 minute then undergo magnetic resonance spectroscopic imaging MRSI over less than 5 minutes Patients may also receive an optional C-2 labeled hyperpolarized carbon C 13 pyruvate IV and undergo MRSI within 15-60 minutes following completion of the first scan
COHORT B MULTIPLE TIME-POINT Patients receive C-1 labeled hyperpolarized carbon C 13 pyruvate IV over less than 1 minute then undergo MRSI over less than 5 minutes Patients may also receive an optional C-2 labeled hyperpolarized carbon C 13 pyruvate IV and undergo MRSI within 15-60 minutes following completion of the first scan at baseline and 12 weeks
After completion of study treatment patients are followed up periodically
I To determine the kPL metabolic flux from hyperpolarized HP 1-13Cpyruvate to 1-13Clactate and kPG metabolic flux from HP 2-13Cpyruvate to 5-13Cglutamate within target lesion Cohort A II To determine the mean percent change from baseline in intra-tumoral kPL and kPG within target lesion Cohort B
SECONDARY OBJECTIVE
I To descriptively report on the intra-tumor heterogeneity in kPL and kPG measurement within target lesion Cohorts A and B
EXPLORATORY CORRELATIVE OBJECTIVES
I To determine if the change from baseline in kPL and kPG is associated with subsequent clinical outcomes on treatment including prostate specific antigen PSA response rate and radiographic progression-survival by Prostate Cancer Working Group 3 PCWG3 criteria Cohort B II In target lesions that are measurable by Response Evaluation Criteria in Solid Tumors RECIST 11 criteria to determine whether baseline andor change from baseline in intratumoral kPL and kPG is associated with subsequent objective response by RECIST criteria Cohort B III To determine the mean percent change from baseline in peak intra- tumoral HP lactate lacpyruvate pyr and glutamate glupyr ratios on repeat metabolic magnetic resonance imaging MRI obtained at the time of radiographic disease progression by PCWG3 criteria Cohort B IV To investigate for association between HP kPL and kPG as well as area under the curve AUC lacpyr and glupyr ratios with tissue- based markers of elevated lactate and glutamate metabolism including MYC and Lactate dehydrogenase A LDHA and Pyruvate dehydrogenase PDH protein expression In participants who undergo optional tumor biopsy Cohort A or B V To investigate for an association between HP kPL and kPG as well as area under the curve AUC lacpyr and glupyr ratios with histologic evidence of small cellneuroendocrine differentiation In participants who undergo optional tumor biopsy Cohort A or B
OUTLINE Patients are assigned to 1 of 2 cohorts
COHORT A SINGLE TIME-POINT Patients receive C-1 labeled hyperpolarized carbon C 13 pyruvate intravenously IV over less than 1 minute then undergo magnetic resonance spectroscopic imaging MRSI over less than 5 minutes Patients may also receive an optional C-2 labeled hyperpolarized carbon C 13 pyruvate IV and undergo MRSI within 15-60 minutes following completion of the first scan
COHORT B MULTIPLE TIME-POINT Patients receive C-1 labeled hyperpolarized carbon C 13 pyruvate IV over less than 1 minute then undergo MRSI over less than 5 minutes Patients may also receive an optional C-2 labeled hyperpolarized carbon C 13 pyruvate IV and undergo MRSI within 15-60 minutes following completion of the first scan at baseline and 12 weeks
After completion of study treatment patients are followed up periodically
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 |
|---|---|---|---|
| U01EB026412 | NIH | None | None |
| R01CA215694 | NIH | None | httpsreporternihgovquickSearchR01CA215694 |