Ignite Creation Date:
2024-05-06 @ 4:05 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02450201
Status:
TERMINATED
Last Update Posted:
2018-10-23
First Post:
2015-05-18
Brief Title:
MRI With C13 Pilot Study Prostate Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Pilot Study to Evaluate the Reproducibility of Magnetic Resonance MR Imaging With Hyperpolarized Pyruvate 13C and Its Ability to Reflect Treatment Effects in Patients With Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2018-10
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:
None
Brief Summary:
This is a pilot clinical study of hyperpolarized pyruvate 13C injection that includes the acquisition of magnetic resonance MR data and will be performed in men with localized prostate cancer Part 1 Five patients will be evaluated for reproducibility of 13C HP MR imaging measurements obtained 2-3 weeks apart with no interim treatment Part 2 Five patients will be evaluated for the change in 13C HP MR imaging measurements after 2 months of ADT
13C HP MR data will be acquired in two parts of the study which can occur simultaneously Part 1 Patients will undergo imaging at baseline and will be repeated two to three weeks later with no intervention in the interim to evaluate reproducibility
Part 2 Patients will undergo imaging at baseline initiate androgen deprivation therapy and undergo repeat imaging two months after initiation of ADT to evaluate the ability of the imaging to reflect a metabolic response to treatment
The change in pyruvatelactate ratio and lactate levels will be measured and compared to baseline at these timepoints
13C HP MR data will be acquired in two parts of the study which can occur simultaneously Part 1 Patients will undergo imaging at baseline and will be repeated two to three weeks later with no intervention in the interim to evaluate reproducibility
Part 2 Patients will undergo imaging at baseline initiate androgen deprivation therapy and undergo repeat imaging two months after initiation of ADT to evaluate the ability of the imaging to reflect a metabolic response to treatment
The change in pyruvatelactate ratio and lactate levels will be measured and compared to baseline at these timepoints
Detailed Description:
None
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