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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA249151 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Massachusetts Institute of Technology | OTHER |
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This study will evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing radical prostatectomy in participants with prostate cancer.
This prospective, single-arm feasibility study is to evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing robot-assisted laparoscopic radical prostatectomy (RP) in participants with prostate cancer. A nonlinear microscope is a rapid imaging technology that can quickly image the surface of the prostate after it has been removed from the body to see if there is any cancer left behind.
The U.S. Food and Drug Administration (FDA) has not approved the NLM device for use in assessing radical prostatectomy surgical specimens but has been approved for other uses.
The research study procedures include screening for eligibility and standard of care radical prostatectomy surgery.
It is expected about 20 people will participate in this research study.
The National Institutes of Health is supporting this research study by providing study funds.
The Masssachusetts Institute of Technology (MIT) is supporting this research by providing the nonlinear microscope.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonlinear Microscopy | Experimental | Enrolled participants will undergo standard-of-care robot-assisted radical prostatectomy surgery utilizing NLM (Nonlinear Microscopy) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonlinear Microscope (NLM) | Device | The nonlinear microscope (NLM) is an imaging device used for intraoperative imaging of prostatectomy specimens to assess surgical margins. |
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| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Success Rate | Enrollment success rate is defined as the proportion of eligible participants enrolled relative to the prespecified enrollment target. | From screening through informed consent completion (up to Day 0 or baseline visit). |
| Retention Success Rate | Retention success rate is defined as the probability of enrolled participants who completed the required study procedures and the follow-up period. | Up to 30 days post-surgery. |
| Technical and Workflow Feasibility Rate | Feasibility rate is defined as the proportion of enrolled participants undergoing robot-assisted radical prostatectomy for whom intraoperative NLM-based specimen margin evaluation meets all predefined feasibility criteria, including timely actionable pathologic feedback, effective real-time communication, and the ability to perform secondary NVB resection when indicated. | On the day of robot-assisted radical prostatectomy (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of Surgical Margin Status Between Intraoperative Nonlinear Microscopy (NLM) and Postoperative Formalin-Fixed Paraffin-Embedded Hematoxylin and Eosin (FFPE H&E) Assessment | Surgical margins will be classified as positive or negative by both intraoperative NLM and postoperative FFPE H&E, with FFPE H&E serving as the reference standard. The unit of analysis for concordance will be per side, aligning with the unit of surgical action. Concordance will be evaluated by comparing margin status determinations across corresponding margin locations. Separate concordance estimates will be calculated for initial nerve-sparing excision specimens (typically 1-2 per participant) and for neurovascular bundle secondary resections, which are relatively rare and are expected in approximately 1-2 per 20 participants. |
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Inclusion Criteria:
Exclusion Criteria:
Male or assigned male at birth (AMAB).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Chang, MD | Contact | 617-667-3739 | pchang@bidmc.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter Chang, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | 02215 | United States |
The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Up to 30 days post-surgery. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |