Urologic Lymphadenectomy in AMIGO

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05132283
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Matthew Mossanen, MD
Phone	(617) 732-6384
Email	mmossanen@bwh.harvard.edu
Status	Recruiting
Phase	N/A
Start date	April 1, 2022
Completion date	December 26, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06065891` - Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer	N/A
Recruiting	`NCT06135571` - Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer
Completed	`NCT06399159` - Prediction of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma Based on Ultrasound and Cytological Images
Completed	`NCT00964977` - Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.	Phase 3
Enrolling by invitation	`NCT06048146` - A Prospective, Multicenter Randomized Controlled Study of the Application of Preoperative FOLFOXIRI Chemotherapy Combined With Lateral Lymph Node Dissection in Low- and Medium-lying Rectal Cancer With Lateral Lymph Node Metastasis	N/A
Recruiting	`NCT05720598` - Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer	N/A
Recruiting	`NCT05970913` - PET-CT Predicting Segement Specific Lymph Nodes Metastasis
Recruiting	`NCT02142244` - Fluorescence Surgery for Sentinel Node Identification in Melanoma	N/A
Enrolling by invitation	`NCT06273501` - MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer	N/A
Completed	`NCT02704988` - Clinical Trial Comparing Carnoy's and GEWF Solutions	N/A
Completed	`NCT06401590` - Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting
Not yet recruiting	`NCT06264167` - NODE (groiN ultrasOunD cancEr)	N/A
Recruiting	`NCT03588416` - Multicentric Study About Pathological Risk Factors for Lymph Node Metastasis in Malignant Colorectal Polyps
Recruiting	`NCT05754814` - SUper-Resolution Ultrasound Imaging of Erythrocytes (SURE) in Normal and Malignant Lymph Nodes
Not yet recruiting	`NCT05375526` - Magtrial: Magtrace® as Tracer for Sentinel Lymph Node Detection in Early Stage Epithelial Ovarian Cancer	N/A
Completed	`NCT05867095` - Navigated Abdominal Lymph Node Dissections	N/A
Not yet recruiting	`NCT05336643` - Radioisotope and Fluorescence Guidance in Rectal Cancer	N/A
Recruiting	`NCT05573451` - Comparison of the Accuracy of US, MRI and PET/CT in the Assessment of LNs in Cervical Cancer.
Completed	`NCT06256185` - Machine Learning to Predict Lymph Node Metastasis in T1 Esophageal Squamous Cell Carcinoma	N/A
Recruiting	`NCT05707312` - Staging Endometrial caNcer Based on molEcular ClAssification