Back to resultsA Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest
Primary Purpose
Urologic Cancer, Urologic Neoplasms, Bladder Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electromagnetic Guided Laparoscopy
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Urologic Cancer focused on measuring Lymph Node Dissection, Urologic Cancer, Urologic Neoplasms, Bladder Cancer, Prostate Cancer, Testicular Cancer, Kidney Cancer, Urethral Cancer, Penile Cancer
Eligibility Criteria
Inclusion Criteria: Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected diagnosis of disease in urologic regions of interest, with scheduled confirmatory surgical biopsy. Subjects must have had either of the following scans: CT, PET or MR of acceptable quality at Brigham and Women's Hospital within the past year. Subjects must also be scheduled to undergo lymph node dissection for a urologic cancer or organ removal of any of the following urologic regions of interest: Bladder, Prostate, Testicle, Ureter, Kidney, Urethra, Penis, and Scrotum Subjects must also be scheduled to undergo a laparoscopic lymph node dissection and/or a urologic organ removal within any OR at BWH. Exclusion Criteria: Severely impaired renal function with an EGFR < 30 mL/min/body surface area Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, which is to be judged at the discretion of the PI History of hypersensitivity or other contraindication to contrast media Contraindication to general anesthesia Pregnancy
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electromagnetic Guided Laparoscopy + Ultrasound
Arm Description
This trial will investigate the use of the novel imaging protocol patients who have a confirmed cancer diagnosis in any of the following urologic regions or organs: Bladder, Prostate, Testicle, Ureter, Kidney, Urethra, Penis, and Scrotum. - This research study involves the use of a standard of care laparoscope and ultrasound probe. The laparoscope and ultrasound probe will have an electromagnetic sensor attached which will assist in the tracking of lymph nodes of interest or organs of interest. It is expected that the entire time to record the data will be less than 10 minutes. standard of care laparoscope and ultrasound probe
Outcomes
Primary Outcome Measures
Laparoscope Images
Laparoscope images are images recorded by the laparoscope surgical device.
Ultrasound Images
Ultrasound Images are images taken by an ultrasound probe.
Electromagnetic Tracking Data
Electromagnetic tracking data is gathered from the movements made by the laparoscope surgical device during surgery. First-order statistics measures will be computed, which include Kinematics metrics such as laparoscope path length, velocity, acceleration, and jerk.
We will analyze the data using a mixed model regression analysis with kinematics metrics as the response and subject as the random effect. Since the kinematics measures are time series, we will address the temporal correlation in this regression model. The fixed effects in this model will include target tissue type, CT Hansfield units, surgeon assessment of navigation difficulty, and patient's BMI. We will test for kinematics outliers by applying the Grubb's test. If there are kinematics outliers, we will try to explain them by going back to the scan and patient history.
Secondary Outcome Measures
Retrospective navigation accuracy
We are collecting data for future assessment of navigation systems, in those studies the primary out will be navigation accuracy
We will analyze the data using a mixed model regression analysis with navigation accuracy as the response and subject as the random effect, as above. We will test for accuracy outliers by applying the Grubb's test and investigate accuracy outliers.
Full Information
NCT ID
NCT05899361
First Posted
March 8, 2023
Last Updated
October 23, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Siemens Medical Solutions
1. Study Identification
Unique Protocol Identification Number
NCT05899361
Brief Title
A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest
Official Title
A Pilot Study of a Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest for Surgical Dissection Within Urologic Regions of Interest.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
August 26, 2025 (Anticipated)
Study Completion Date
December 25, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Siemens Medical Solutions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research study is a pilot clinical trial, which hypothesizes that the combination of electromagnetic tracking in conjunction with laparoscope imaging and ultrasound probe imaging will aid in reducing the complexity of both laparoscopic lymphadenectomy and/or organ removal in patients with a confirmed diagnosis of cancer in urologic regions of interest (Bladder, Prostate, Testicular, Kidney, Urethral, and Penis), by resulting in better visualization and more accurate localization of certain areas in the diseased organ or the diseased lymph node, and allowing for improved surgical and patient outcomes, fewer complications and better clinician performance.
Detailed Description
Participants in this research study, may or may not have a tumor within a urologic region of interest such as the bladder, prostate, testicle, kidney, urethra, and penis which may or may not have spread to a lymph node and have been scheduled to undergo a lymph node dissection procedure and/or organ removal surgery within one of the previously mentioned urologic regions of interest concerning for urologic cancer.
This research study involves the use of a standard of care laparoscope and ultrasound probe. The laparoscope and ultrasound probe will have an electromagnetic sensor attached which will assist in the tracking of lymph nodes of interest or organs of interest.
It is expected that the entire time to record the data will be less than 10 minutes.
A total of 10 people will take part in this research study
This study is supported by Siemens Medical USA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Cancer, Urologic Neoplasms, Bladder Cancer, Prostate Cancer, Testicular Cancer, Kidney Cancer, Urethral Cancer, Penile Cancer
Keywords
Lymph Node Dissection, Urologic Cancer, Urologic Neoplasms, Bladder Cancer, Prostate Cancer, Testicular Cancer, Kidney Cancer, Urethral Cancer, Penile Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electromagnetic Guided Laparoscopy + Ultrasound
Arm Type
Experimental
Arm Description
This trial will investigate the use of the novel imaging protocol patients who have a confirmed cancer diagnosis in any of the following urologic regions or organs: Bladder, Prostate, Testicle, Ureter, Kidney, Urethra, Penis, and Scrotum.
- This research study involves the use of a standard of care laparoscope and ultrasound probe. The laparoscope and ultrasound probe will have an electromagnetic sensor attached which will assist in the tracking of lymph nodes of interest or organs of interest. It is expected that the entire time to record the data will be less than 10 minutes. standard of care laparoscope and ultrasound probe
Intervention Type
Device
Intervention Name(s)
Electromagnetic Guided Laparoscopy
Intervention Description
Standard Care
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Standard Care
Primary Outcome Measure Information:
Title
Laparoscope Images
Description
Laparoscope images are images recorded by the laparoscope surgical device.
Time Frame
1 year
Title
Ultrasound Images
Description
Ultrasound Images are images taken by an ultrasound probe.
Time Frame
1 year
Title
Electromagnetic Tracking Data
Description
Electromagnetic tracking data is gathered from the movements made by the laparoscope surgical device during surgery. First-order statistics measures will be computed, which include Kinematics metrics such as laparoscope path length, velocity, acceleration, and jerk.
We will analyze the data using a mixed model regression analysis with kinematics metrics as the response and subject as the random effect. Since the kinematics measures are time series, we will address the temporal correlation in this regression model. The fixed effects in this model will include target tissue type, CT Hansfield units, surgeon assessment of navigation difficulty, and patient's BMI. We will test for kinematics outliers by applying the Grubb's test. If there are kinematics outliers, we will try to explain them by going back to the scan and patient history.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Retrospective navigation accuracy
Description
We are collecting data for future assessment of navigation systems, in those studies the primary out will be navigation accuracy
We will analyze the data using a mixed model regression analysis with navigation accuracy as the response and subject as the random effect, as above. We will test for accuracy outliers by applying the Grubb's test and investigate accuracy outliers.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management
Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected diagnosis of disease in urologic regions of interest, with scheduled confirmatory surgical biopsy.
Subjects must have had either of the following scans: CT, PET or MR of acceptable quality at Brigham and Women's Hospital within the past year.
Subjects must also be scheduled to undergo lymph node dissection for a urologic cancer or organ removal of any of the following urologic regions of interest: Bladder, Prostate, Testicle, Ureter, Kidney, Urethra, Penis, and Scrotum
Subjects must also be scheduled to undergo a laparoscopic lymph node dissection and/or a urologic organ removal within any OR at BWH.
Exclusion Criteria:
Severely impaired renal function with an EGFR < 30 mL/min/body surface area
Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, which is to be judged at the discretion of the PI
History of hypersensitivity or other contraindication to contrast media
Contraindication to general anesthesia
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Mossanen, MD
Phone
617-525-6348
Email
mmossanen@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Mossanen, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Mossanen, MD
Phone
617-732-6384
Email
mmossanen@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Matthew Mossanen, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center 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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation
Learn more about this trial
A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest
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