Ignite Creation Date:
2024-05-06 @ 9:10 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02911467
Status:
TERMINATED
Last Update Posted:
2020-07-24
First Post:
2016-09-19
Brief Title:
Magnetic Resonance MR Imaging With Hyperpolarized Pyruvate HP 13C in Castration-Resistant Prostate Cancer
Sponsor:
Rahul Aggarwal
Organization:
University of California San Francisco
Study Overview
Official Title:
Magnetic Resonance MR Imaging With Hyperpolarized Pyruvate 13C as a Predictive Biomarker of Response to Androgen Signaling Inhibitors in Castration-Resistant Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MR
Brief Summary:
This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging with Hyperpolarized Pyruvate HP 13C as a predictive response biomarker to androgen signaling inhibition in patients with castration-resistant prostate cancer
Detailed Description:
This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging as a predictive response biomarker to androgen signaling inhibition in patients with castration-resistant prostate cancer Patients with a target lesion that is amenable for metabolic MR imaging will be eligible for study participation Patients will undergo baseline metabolic MR imaging with Hyperpolarized Pyruvate C-13 pyruvate followed by initiation of androgen signaling inhibition either as standard of care or as part of clinical trial including abiraterone andor enzalutamide treatment Patient will subsequently undergo repeat metabolic MR scan after 28 days - 7 days of therapy For those without primarily refractory disease a third metabolic MR scan will be completed at the time of radiographic disease progression by The Prostate Cancer Clinical Trials Working Group 2 PCWG2 criteria MR- or CT-guided tumor biopsies are optional at baseline and at the time of disease progression
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 |
|---|---|---|---|
| 5R01CA166655-04 | NIH | None | httpsreporternihgovquickSearch5R01CA166655-04 |