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Confocal Microscopy Detects Prostate Cancer Margins During Surgery

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Summary

NIH has registered clinical trial NCT07541911, evaluating the LaserSAFE confocal microscopy technique for detecting positive cancer margins during radical prostatectomy. The single-arm study will assess whether real-time intraoperative imaging can improve surgeons' nerve-preservation decision-making compared to standard practice. Participants undergo standard prostate surgery with initial nerve-sparing intent, followed by LaserSAFE analysis of the removed prostate, with additional tissue excision guided by the technique.

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What changed

NIH registered a new clinical trial (NCT07541911) on ClinicalTrials.gov studying the LaserSAFE confocal microscopy technique. The trial will enroll patients undergoing radical prostatectomy to evaluate whether intraoperative imaging can accurately detect cancer at the prostate margin (positive margins) and assist surgeons in deciding whether to preserve or remove surrounding nerves. Participants complete quality-of-life questionnaires pre- and post-surgery, and additional tissue is excised if LaserSAFE identifies cancer at the margins.

Affected parties include clinical investigators conducting prostate cancer surgical trials, medical device manufacturers developing intraoperative imaging technologies, and hospital research programs in urologic oncology. The trial does not create any compliance or regulatory obligations for external parties — it is an informational registry entry describing a research protocol.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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A Study to Evaluate the Performance of Confocal Microscopy to Detect Positive Margins During Radical Prostatectomy

N/A NCT07541911 Kind: NA Apr 21, 2026

Abstract

The goal of this study is to find out whether a new method called "LaserSAFE" can accurately detect cancer at the edge of the prostate (called a positive margin) during prostate surgery. LaserSAFE uses a special microscope in the operating room to quickly scan the prostate after it has been removed from the body. This information can help surgeons decide whether it is safe to preserve the nerves around the prostate. This is especially important for patients who are not usually considered suitable for nerve-sparing surgery using current methods. The study will also assess how quickly and reliably LaserSAFE provides this information during surgery.

The main questions it aims to answer are:

Can LaserSAFE accurately detect cancer at the edges of the prostate during surgery? Can LaserSAFE help surgeons safely decide whether to preserve or remove the surrounding nerves?

Researchers will evaluate the use of the LaserSAFE technique during surgery to see if it improves decision-making about nerve preservation compared to standard practice.

Participants will:

Complete a quality of life questionnaire before surgery Undergo standard prostate surgery, where the surgeon will initially try to preserve the nerves Have their removed prostate analysed during surgery using the LaserSAFE technique Have additional tissue removed if LaserSAFE detects cancer at the edges of the prostate Attend routine follow-up visits as part of standard care Complete quality of life questionnaires at 3 and...

Conditions: Prostate Cancer, Prostate Cancer (Adenocarcinoma)

Interventions: LaserSAFE

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
3254.1 Biotechnology
Activity scope
Clinical trial registration Intraoperative imaging study
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Pharmaceuticals

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