Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Prostatic Neoplasms

Carcinoma, Renal Cell

Urinary Bladder Neoplasms

Urologic Neoplasms

Testicular Neoplasms

Kidney Neoplasms

Carcinoma

Urethral Neoplasms

Penile Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Kidney Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urethral Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Penile Diseases

Renal Cell Carcinoma

Penile Cancer

Urethral Cancer

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

Electromagnetic Guided Laparoscopy

Ultrasound

Matthew Mossanen, MD

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.

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.

A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest

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.

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.

Laparoscope images are images recorded by the laparoscope surgical device.

Ultrasound Images are images taken by an ultrasound probe.

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.

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.

Siemens Medical Solutions

Dana-Farber Cancer Institute

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest	NCT05899361	Urologic Cancer Urologic Neopla... Bladder Cancer Prostate Cancer Testicular Canc... Kidney Cancer Urethral Cancer Penile Cancer	Electromagnetic... Ultrasound	18 Years -	Dana-Farber Cancer Institute
A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest	NCT05899361	Urologic Cancer Urologic Neopla... Bladder Cancer Prostate Cancer Testicular Canc... Kidney Cancer Urethral Cancer Penile Cancer	Electromagnetic... Ultrasound	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for electromagnetic guided laparoscopy