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Urologic Lymphadenectomy in AMIGO

Primary Purpose

Urologic Cancer, Lymph Node Metastasis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D Slicer
Monaco
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urologic Cancer focused on measuring Urologic Cancer, Lymph Node Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 a CT, PET or MR examination of acceptable quality at Brigham and Women's Hospital within the prior month.
  • Subjects must also be scheduled to undergo lymphadenectomy for a urologic cancer within the following urologic regions of interest: Bladder, Prostate, Testicular, Kidney, Urethral, and Penile.
  • Subjects must also be scheduled to undergo a laparoscopic lymphadenectomy within the AMIGO OR

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

Urologic Lymphadenectomy in AMIGO

Arm Description

Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).

Outcomes

Primary Outcome Measures

Proportion of Patients Completing Intended Procedure (Feasibility)
The Slicer-Monaco prototype navigation platform will be used to resect enlarged and/or fluorodeoxyglucose avid lymph nodes. The successful navigational use of this platform will be considered as completed. The proportion of patients completing this intended procedure will be reported.

Secondary Outcome Measures

Proportion of Patients with Laparoscopic Videos Recorded
During the first phase of the project on 10 patients, we will store real-time laparoscopic videos using the KARL STORZ 3D Video system that can be analyzed offline. During the second phase of 10 patients, we will provide an optional video overlay option in the navigation system. The navigation system will be similar to that used on the first 10 patients. The only difference will be that the virtual endoscopy view will be overlaid on the laparoscopy video in the 3D Slicer navigation system.
Path length Kinematic Metric
The kinematic metric of path length will be computed using recorded data from the navigation system. Mean path length scores for all patients will be reported for each kinematic measure.
Velocity Kinematic Metric
The kinematic metric of velocity will be computed using recorded data from the navigation system. Mean velocity scores for all patients will be reported for each kinematic measure.
Acceleration Kinematic Metric
The kinematic metric of acceleration will be computed using recorded data from the navigation system. Mean acceleration scores for all patients will be reported for each kinematic measure.
Jerk Kinematic Metric
The kinematic metric of jerk will be computed using recorded data from the navigation system. Mean jerk scores for all patients will be reported for each kinematic measure.
Mental/Physical/Temporal Demand on Physician
The mental, physical and temporal demand on physicians will be assessed using the NASA Task Load Index (NASA-TLX), a multidimensional assessment tool that rates perceived workload in order to assess the performance of a task. The NASA task load index has a scoring range of 1 to 10 for mental demand, physical demand, temporal demand, effort, and frustration with 1 representing a very low value and 10 representing a very high value. A mean score out of 10 will be given for each operation and a mean score for all 20 operations will be given (out of 10). Assessment will be filled out by investigators.
Mean absolute difference in distance from Instruments to Organs
The accuracy of localization of the organs will be quantified by pointing to specific structures and evaluating the distance of the registered instrument from the structures in the image space.
Further, the pathology of the lymph node resected using the navigation system will be compared to the other lymph nodes resected in urologic regions of interest.
To ensure quality control of the procedure, the lymph node removed with the navigation system will be compared to the other lymph nodes resected in urologic regions of interest without the use of the navigation system. The unit of measure will be the accuracy of targeting the PET-avid lymph node as confirmed by pathology, i.e., binary decision variable for two categories (using the navigation system or not). Using the navigation system: malignant or not, versus not using with the navigation system: malignant or not. The measurement tool will be the pathological analysis.

Full Information

First Posted
November 1, 2021
Last Updated
October 23, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05132283
Brief Title
Urologic Lymphadenectomy in AMIGO
Official Title
Image-guided Lymphadenectomy Within Urologic Regions of Interest in AMIGO
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 26, 2025 (Anticipated)
Study Completion Date
December 26, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, to simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes) in patients with urological cancer.
Detailed Description
This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, which will simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes). The U.S. Food and Drug Administration (FDA) has not approved the navigation systems (3D Slicer and Monaco) as a treatment for any disease. In this research study, our hypothesis is that the use of the navigation systems (3D Slicer and the Siemens Monaco system) may simplify the complexity of laparoscopic lymphadenectomy (The procedure in which a small incision is made in the lower abdomen to reach the lymph nodes) in regions of urologic interest, by resulting in better visualization and more accurate localization of the diseased lymph node and allowing for improved surgical and patient outcomes, fewer complications, and better clinician performance. The long-term goal of our program is to demonstrate that the navigation system (3D Slicer and the Siemens Monaco system) increase the efficiency and reduce the morbidity or the likelihood of any medical problems associated with the resection or removal of radiologically defined lesions, within urologic regions of interest, associated with any type of urologic cancer. The first clinical application of the system will be in resecting radiologically positive lymph nodes displayed by CT or FDG PET (an imaging test used to identify lymphomas and other cancers) in the Advanced Multimodality Image-Guided Operating (AMIGO) Suite at Brigham and Women's Hospital (BWH). The navigation system has been used with similar protocols, specifically 5 parathyroid surgeries, 13 tracked endoscopic ultrasound (minimally invasive procedure to assess digestive and lung diseases) and over 30 tracked colonoscopy experiments (exam used to detect changes or abnormalities in the large intestine (colon) and rectum) on human subjects at BWH with no difficulties or reportable incidents. It will take you up to 4 weeks to complete this study. During that time you will have two study visits and one standard of care follow-up visit. The research study procedures include: screening for eligibility and study treatment including evaluations and standard of care follow-up visits. It is expected that about 20 people will take part in this research study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Cancer, Lymph Node Metastasis
Keywords
Urologic Cancer, Lymph Node Metastasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Urologic Lymphadenectomy in AMIGO
Arm Type
Experimental
Arm Description
Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).
Intervention Type
Device
Intervention Name(s)
3D Slicer
Intervention Description
Navigational device used during surgery to locate abnormal lymph nodes.
Intervention Type
Device
Intervention Name(s)
Monaco
Intervention Description
Navigational device used during surgery to locate abnormal lymph nodes.
Primary Outcome Measure Information:
Title
Proportion of Patients Completing Intended Procedure (Feasibility)
Description
The Slicer-Monaco prototype navigation platform will be used to resect enlarged and/or fluorodeoxyglucose avid lymph nodes. The successful navigational use of this platform will be considered as completed. The proportion of patients completing this intended procedure will be reported.
Time Frame
One month, up to 45 days after registration
Secondary Outcome Measure Information:
Title
Proportion of Patients with Laparoscopic Videos Recorded
Description
During the first phase of the project on 10 patients, we will store real-time laparoscopic videos using the KARL STORZ 3D Video system that can be analyzed offline. During the second phase of 10 patients, we will provide an optional video overlay option in the navigation system. The navigation system will be similar to that used on the first 10 patients. The only difference will be that the virtual endoscopy view will be overlaid on the laparoscopy video in the 3D Slicer navigation system.
Time Frame
One month, up to 45 days from registration
Title
Path length Kinematic Metric
Description
The kinematic metric of path length will be computed using recorded data from the navigation system. Mean path length scores for all patients will be reported for each kinematic measure.
Time Frame
One month, up to 45 days after registration
Title
Velocity Kinematic Metric
Description
The kinematic metric of velocity will be computed using recorded data from the navigation system. Mean velocity scores for all patients will be reported for each kinematic measure.
Time Frame
One month, up to 45 days after registration
Title
Acceleration Kinematic Metric
Description
The kinematic metric of acceleration will be computed using recorded data from the navigation system. Mean acceleration scores for all patients will be reported for each kinematic measure.
Time Frame
One month, up to 45 days after registration
Title
Jerk Kinematic Metric
Description
The kinematic metric of jerk will be computed using recorded data from the navigation system. Mean jerk scores for all patients will be reported for each kinematic measure.
Time Frame
One month, up to 45 days after registration
Title
Mental/Physical/Temporal Demand on Physician
Description
The mental, physical and temporal demand on physicians will be assessed using the NASA Task Load Index (NASA-TLX), a multidimensional assessment tool that rates perceived workload in order to assess the performance of a task. The NASA task load index has a scoring range of 1 to 10 for mental demand, physical demand, temporal demand, effort, and frustration with 1 representing a very low value and 10 representing a very high value. A mean score out of 10 will be given for each operation and a mean score for all 20 operations will be given (out of 10). Assessment will be filled out by investigators.
Time Frame
One month, up to 45 days after registration
Title
Mean absolute difference in distance from Instruments to Organs
Description
The accuracy of localization of the organs will be quantified by pointing to specific structures and evaluating the distance of the registered instrument from the structures in the image space.
Time Frame
One month, up to 45 days after registration
Title
Further, the pathology of the lymph node resected using the navigation system will be compared to the other lymph nodes resected in urologic regions of interest.
Description
To ensure quality control of the procedure, the lymph node removed with the navigation system will be compared to the other lymph nodes resected in urologic regions of interest without the use of the navigation system. The unit of measure will be the accuracy of targeting the PET-avid lymph node as confirmed by pathology, i.e., binary decision variable for two categories (using the navigation system or not). Using the navigation system: malignant or not, versus not using with the navigation system: malignant or not. The measurement tool will be the pathological analysis.
Time Frame
One month, up to 45 days after registration

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 a CT, PET or MR examination of acceptable quality at Brigham and Women's Hospital within the prior month. Subjects must also be scheduled to undergo lymphadenectomy for a urologic cancer within the following urologic regions of interest: Bladder, Prostate, Testicular, Kidney, Urethral, and Penile. Subjects must also be scheduled to undergo a laparoscopic lymphadenectomy within the AMIGO OR 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) 732-6384
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

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Urologic Lymphadenectomy in AMIGO

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