Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Fluorophosphate

Protective Agents

SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.

SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.

Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

ISB dye and standard white light imaging

Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.

ICG dye and FireFly fluorescence imaging

Robert Holloway, MD

The investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with Technesium-99 and ISB colorimetric dye, SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. SLN biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine H\&E pathologic analysis.

The study objective is to compare two sentinel lymph node detection technologies \[fluorescence imaging and Indocyanine Green (ICG) dye verses standard laparoscopic colorimetric analysis using Isosulfan Blue (ISB) dye\] for sensitivity and specificity of detecting metastatic disease in pelvic lymph nodes of women with endometrial cancer undergoing robotic-assisted laparoscopic hysterectomy and lymphadenectomy. The following three specific aims would be addressed in this research proposal:

Specific Aim 1: To determine the ability of mapping bilaterally pelvic SLN in women with endometrial cancer undergoing robotic-assisted laparoscopic staging comparing two different methods (i.e., comparing the combination of colorimetric analysis-ISB dye + fluorescence imaging-ICG dye vs. colorimetric analysis-ISB dye alone).

Specific Aim 2: To estimate the negative predictive value (NPV) of pelvic SLN in endometrial cancer with respect to predicting nodal metastasis.

Specific Aim 3: To evaluate the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H\&E) results.

Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG

Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue (ISB) and Indocyanine Green Dyes (ICG) With Fluorescence Imaging

Of the 127 positive nodes with pathology information, the percentage of each type of node will be summarized by the staining method. Statistical testing of the individual staining methods compared to both will be computed using Chi-square test of independence.

The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients.

NPV = 140/141=99.3%

AdventHealth

ISB only Adverse Events categories reported during post-op follow up 6 weeks

ISB Only Adverse Events

ICG Adverse Events categories reported during post-op follow up 6 weeks

ICG Adverse Events

SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.

ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

ISB Dye, Standard White Light

SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.

ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.

ICG Dye, FireFly Fluorescence Imaging

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Robert W. Holloway

The ISB dye alone group (n=20) and the ICG group (n=180) are combined, because both groups received the ISB dye.

Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.

Metastatic Disease

Non Metastatic Disease

Experimental subjects with Indocyanine Green (ICG) negative test results

ICG Negative

Experimental subjects with Indocyanine Green (ICG) positive test results

ICG Positive

Comparison of metastatic disease (yes or no) with ICG dye node detection (yes or no)

Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.

Sentinel Nodes

Pelvic Nodes Only

Aortic

Infrarenal

Positive node identified with IHC dye only

IHC Only

H&E Only

Positive node identified with both IHC and H\&E dye

Both IHC and H&E

Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures

Subjects randomized to this arm will undergo conventional open NSM procedures

Robotic-assisted Nipple sparing mastectomy procedures

Robotic NSM

open nipple-sparing mastectomy procedures

Open NSM

Kathryn Wine

Jennifer Tseng, MD

Stephanie Casal, MS, RN, CNS

Jamie Rand, MD

Mouchammed Agko, MD

Antoine Carre, MD

Katharine Schulz-Costello, DO

Farin Amersi, MD

Alice Chung, MD

Kjirsten Carlson, MD

Marissa Boyle, MD

Edward Ray, MD

Adna Makerevic

James Jakub, MD

Brian Rinker, MD

Sarah McLaughlin, MD

Olivia Ho, MD

Tammeza Gibson, PA

Cathy Graham, MD

Clara Farley, MD

Sarah Apatov, PA

Peter Thompson, MD

Duanny Alva

Anne Jankowski

Katherine Kopkash, MD

Nayana Dekhne, MD

Jesse Selber, MD

Mara Piltin, DO

Clinical Coordinator

Rebecca Aft, MD

Joani Christensen, MD

Sabah Iqbal

Alan Kadison, MD

Gary Deutsche, MD

Neil Tanna, MD

Armen Kasabian, MD

Kimberly Turnage, MSN

Adi Molvin

Akiko Chiba, MD

Shelley Hwang, MD

Laura Rosenberger, MD

Geoffrey Sisk, MD

Rebecca Knackstedt, MD

Maggie Dinome, MD

Juliana Ruiz

Ari Brooks, MD

Kathy Taylor

Kelly Hewitt, MD

John Tran

Rosa Hwang, MD

Solange Cox, MD

Renee Largo, MD

John Shuck, MD

Erin Fannon

Sara Javid, MD

Meghan Flanagan, MD

Suzanne Marie Inchauste, MD

Alysandra Lal, MD

John Yousif, MD

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM

Robotic vs. Open NSM for Early Stage Breast Cancer

A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures

Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery

Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG	NCT02068820	Endometrial Can...	ISB dye and sta... ICG dye and Fir...	18 Years - 85 Years	AdventHealth
Robotic vs. Open NSM for Early Stage Breast Cancer	NCT05720039	Breast Cancer F... Breast Cancer Breast Cancer, ... Breast Disease Breast	Robotic NSM Open NSM	21 Years -	Intuitive Surgical
Robotic vs. Open NSM for Early Stage Breast Cancer	NCT05720039	Breast Cancer F... Breast Cancer Breast Cancer, ... Breast Disease Breast	Robotic NSM Open NSM	21 Years -	Intuitive Surgical
A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer	NCT04831580	Cervical Cancer	da Vinci open surgery	18 Years -	GOG Foundation
A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer	NCT04831580	Cervical Cancer	da Vinci open surgery	18 Years -	GOG Foundation
A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer	NCT04831580	Cervical Cancer	da Vinci open surgery	18 Years -	GOG Foundation
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG	NCT02068820	Endometrial Can...	ISB dye and sta... ICG dye and Fir...	18 Years - 85 Years	AdventHealth

Spots Global Cancer Trial Database for da vinci

Every month we try and update this database with for da vinci cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for da vinci

Every month we try and update this database with for da vinci cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for da vinci cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.