Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-03-02 @ 10:05 PM
Study NCT ID:
NCT02680535
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2016-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
Sponsor:
Nanospectra Biosciences, Inc.
Organization:
Study Overview
Official Title:
A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
Status:
COMPLETED
Status Verified Date:
2021-03
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:
To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.
Detailed Description:
This is an open-label, multi-center, single-dose study of AuroLase Therapy in the focal ablation of neoplastic prostate tissue via nanoparticle directed irradiation. The patient population consists of men with low to intermediate risk localized prostate cancer with MRI visible and confirmed focal areas of prostate cancer using MR US Fusion Guided Biopsy. The patient also has no disease detected via ultrasound guided biopsy outside of areas visualized on MR imaging.There is one arm/group to this study: Up to forty five (45) patients will receive a single intravenous infusion of AuroShell particles 12 to 36 hours prior to MRI/US guided laser irradiation using an FDA cleared laser and an interstitial optical fiber.
Efficacy and acute volume of ablation will be assessed by contrast-enhanced MRI 48 - 96 hours after laser illumination to allow time for the appearance of coagulative necrosis and prior to reconfiguration of tissue by lytic action. An appearance of a 'void' on MRI would be more generally expected than lesion shrinkage. Efficacy of focal ablation of prostate tissue will be assessed by MRI /Ultrasound guided biopsy at 3 months (primary endpoint) and again at 1 year after laser treatment. Per standard of care patient follow up will continue on a 6 month basis beyond the one year follow up but will be outside the scope of the study.
Efficacy and acute volume of ablation will be assessed by contrast-enhanced MRI 48 - 96 hours after laser illumination to allow time for the appearance of coagulative necrosis and prior to reconfiguration of tissue by lytic action. An appearance of a 'void' on MRI would be more generally expected than lesion shrinkage. Efficacy of focal ablation of prostate tissue will be assessed by MRI /Ultrasound guided biopsy at 3 months (primary endpoint) and again at 1 year after laser treatment. Per standard of care patient follow up will continue on a 6 month basis beyond the one year follow up but will be outside the scope of the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: