MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue
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ClinicalTrials.gov Identifier: NCT02680535 |
Recruitment Status :
Completed
First Posted : February 11, 2016
Last Update Posted : March 3, 2021
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Tracking Information | |||
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First Submitted Date ICMJE | February 2, 2016 | ||
First Posted Date ICMJE | February 11, 2016 | ||
Last Update Posted Date | March 3, 2021 | ||
Study Start Date ICMJE | February 2016 | ||
Actual Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Evidence of efficacy of focal ablation of clinically significant targeted prostate lesion(s) confirmed using 3T MRI/Ultrasound guided biopsy 3 months after treatment. [ Time Frame: Three Months ] Efficacy of focal ablation will be assessed by 3T MRI/Ultrasound guided biopsy at 3 months after treatment. Focal ablation of clinically significant targeted prostate lesions(s) as confirmed with negative biopsies with minimal damage to surrounding healthy tissue.
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Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue | ||
Official Title ICMJE | A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue | ||
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. |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Neoplasms of the Prostate | ||
Intervention ICMJE | Device: AuroShell particle infusion
Infuse AuroShell particles for irradiation by AuroLase laser to ablate neoplasms of the prostate.
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Study Arms ICMJE | Experimental: AuroShell particle infusion
Single intravenous infusion of AuroShell particles 12 to 36 hours prior to ultrasound-guided laser irradiation using a FDA cleared laser and an interstitial optical fiber.
Intervention: Device: AuroShell particle infusion
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
45 | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date ICMJE | October 2020 | ||
Actual Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 45 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02680535 | ||
Other Study ID Numbers ICMJE | NBI-PC-002 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Responsible Party | Nanospectra Biosciences, Inc. | ||
Study Sponsor ICMJE | Nanospectra Biosciences, Inc. | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Nanospectra Biosciences, Inc. | ||
Verification Date | March 2021 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |