Surgical Guidance Technology for Urologic Cancer Surgery

Overseen By Matthew Mossanen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Severely impaired renal function, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates two navigation systems designed to assist doctors in performing surgeries that remove lymph nodes in individuals with urologic cancer. The aim is to enhance the ease and precision of these surgeries through advanced imaging technology. Known as Urologic Lymphadenectomy, this surgery involves the removal of lymph nodes. Individuals with urologic cancer scheduled for this specific surgery at Brigham and Women's Hospital may be suitable candidates. Participants should have undergone a recent CT, PET, or MR scan and be prepared for surgery in areas such as the bladder, prostate, or kidney. As an unphased trial, this study allows participants to contribute to innovative surgical advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these navigation systems are safe for urologic cancer surgery?

Research has shown that using 3D navigation systems like 3D Slicer and the Siemens Monaco system in surgeries is safe. These systems enhance doctors' visibility and precision during operations. Studies have found that robotic methods for removing pelvic lymph nodes, a similar procedure, are safe and effective for treating cancers such as prostate and bladder cancer.

No reports of serious side effects have emerged from using these navigation systems. Patients generally do not experience adverse reactions to the technology. These systems enable doctors to locate and remove lymph nodes more accurately without increasing surgical risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses cutting-edge navigation systems, like 3D Slicer and Monaco, to guide urologic lymphadenectomy procedures. Unlike standard surgical methods, which rely heavily on the surgeon's experience and visual assessment, this technology offers a precise and targeted approach to locate abnormal lymph nodes. This could potentially enhance surgical accuracy and improve outcomes for patients with urologic cancer, making the procedure safer and more effective.

What evidence suggests that these navigation systems are effective for urologic cancer surgery?

In this trial, participants will undergo Urologic Lymphadenectomy with the assistance of navigation systems, including 3D Slicer and Monaco. Studies have shown that pelvic lymph node dissection, a component of this treatment, effectively determines the stage of prostate and bladder cancer, aiding doctors in assessing cancer spread. The use of 3D Slicer software, which aids in planning and guiding surgery, has improved accuracy in locating affected lymph nodes. Research indicates that this technology may help surgeons remove these nodes more precisely, leading to better outcomes. These navigation systems aim to simplify complex surgeries, potentially reducing complications. ^{5 6 7 8 9}

Who Is on the Research Team?

Matthew Mossanen, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed or suspected urologic cancers (bladder, prostate, testicular, kidney, urethral, penile) who need lymph node removal surgery. They must have had a recent quality imaging scan at Brigham and Women's Hospital and be able to undergo general anesthesia without significant health risks.

Inclusion Criteria

I am scheduled for a lymph node removal surgery for cancer in my bladder, prostate, testicle, kidney, urethra, or penis.

I am over 18 and have a possible diagnosis needing a biopsy in my urinary system.

Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management

Exclusion Criteria

History of hypersensitivity or other contraindication to contrast media

I cannot have general anesthesia due to health risks.

Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, to be judged at the discretion of the PI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo lymphadenectomy using the 3D Slicer and Siemens Monaco navigation systems

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (standard of care)

What Are the Treatments Tested in This Trial?

Interventions

• 3D Slicer
• Monaco
• Urologic Lymphadenectomy

Trial Overview The study compares two navigation systems: the 3D Slicer-based system and the Siemens Monaco system. These are used during laparoscopic lymphadenectomy (lymph node removal surgery) to see if they can make this complex procedure simpler for patients with urological cancer.

How Is the Trial Designed?

Group I: Urologic Lymphadenectomy in AMIGO Experimental Treatment 2 Interventions

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

Urologic Lymphadenectomy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Urologic Lymphadenectomy for:

• Urothelial carcinoma of the bladder
• Upper urinary tract urothelial carcinoma
• Prostate cancer
• Penile cancer
• Testicular cancer

Approved in European Union as Urologic Lymphadenectomy for:

• Urothelial carcinoma of the bladder
• Upper urinary tract urothelial carcinoma
• Prostate cancer
• Penile cancer
• Testicular cancer

Approved in Canada as Urologic Lymphadenectomy for:

• Urothelial carcinoma of the bladder
• Upper urinary tract urothelial carcinoma
• Prostate cancer
• Penile cancer
• Testicular cancer

Approved in Japan as Urologic Lymphadenectomy for:

• Urothelial carcinoma of the bladder
• Upper urinary tract urothelial carcinoma
• Prostate cancer
• Penile cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

Pelvic lymph node dissection (PLND) in urologic surgery is important for accurate cancer staging and can be beneficial for patients with lymph node metastases, but it carries risks of complications such as lymphocele and nerve injury.

Advancements in surgical techniques and perioperative care have the potential to reduce the morbidity associated with PLND, making the procedure safer for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of lymphadenectomy in urologic surgery. Williams, SK., Rabbani, F.[2011]

Robotic surgery for urological cancers allows for a minimally invasive approach, but it is crucial to adhere to the surgical principles of open surgery to ensure effective treatment outcomes.

The review highlights the importance of lymph node dissection in various urological cancers, emphasizing that it must be performed carefully to achieve comparable oncological results across different types of cancer, including prostate and bladder cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot assisted lymphadenectomy in urology: pelvic, retroperitoneal and inguinal. Pini, G., Matin, SF., Suardi, N., et al.[2022]

Laparoscopic pelvic lymph node dissection in 103 patients with genitourinary cancers demonstrated a high success rate, with 87-95% of lymph nodes removed laparoscopically in a subgroup evaluated against open dissection.

The procedure resulted in a low complication rate of 13.5%, a mean hospitalization of just 1.6 days, and minimal postoperative narcotic use, indicating a safer and quicker recovery compared to traditional open surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic pelvic lymph node dissection: a review of 103 consecutive cases. Rukstalis, DB., Gerber, GS., Vogelzang, NJ., et al.[2019]

A nomogram was developed to predict the duration of lymphatic drainage in patients with penile cancer after inguinal lymph node dissection, based on a study of 111 groin basins from 56 patients.

Key factors influencing prolonged drainage included younger age, higher body mass index, total number of resected lymph nodes, and the ratio of positive lymph nodes, with the model showing improved predictive accuracy when lymph node variables were included.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nomogram to predict the duration of drainage in patients with penile cancer treated with inguinal lymph node dissection. Zhou, JQ., Zhu, Y., Ye, DW., et al.[2011]

Regional lymph node dissection has shown effective results in treating metastatic testicular cancer, renal cell carcinoma, and transitional cell carcinoma, based on a 17-year clinical experience.

The role of lymphadenectomy in prostate cancer is less clear, primarily serving as a staging procedure rather than a definitive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of regional lymph node dissection in genitourinary cancer. Skinner, DG.[2019]

Pelvic lymph node dissection (PLND) during cystectomy is crucial for accurate cancer staging and can improve cancer control outcomes.

There is ongoing debate about the terminology and the optimal extent of PLND, with some studies indicating that extended PLND may offer additional survival benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lymphadenectomy for bladder cancer: indications and controversies. Burkhard, FC., Roth, B., Zehnder, P., et al.[2011]

In a study of 406 patients undergoing robot-assisted prostate cancer surgery, extended lymph node dissection (ELND) was found to have similar overall and major complication rates compared to limited lymph node dissection (LLND), indicating that ELND can be performed safely with minimal additional risk.

While the operating time and hospital stay were slightly longer for patients undergoing ELND, the procedure effectively increased the detection of lymph node metastases, suggesting potential therapeutic benefits without significantly increasing morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized comparison of robot-assisted limited and extended pelvic lymphadenectomy for prostate cancer. Yuh, BE., Ruel, NH., Mejia, R., et al.[2022]

In high-volume centers, minimally invasive lymphadenectomy for urologic cancers, such as prostate and bladder cancer, shows comparable lymph node yield and oncologic outcomes to traditional open surgery, with prostate cancer achieving nearly 20 lymph nodes harvested on average.

While minimally invasive techniques are promising, especially in prostate cancer, the effectiveness in bladder cancer is still developing, and there is no consensus on lymphadenectomy protocols for kidney and upper tract urothelial cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of minimally invasive versus open lymphadenectomy in urological cancers. Prasad, SM., Shalhav, AL.[2014]

In a study of 170 patients undergoing radical bilateral inguinal lymphadenectomy for penile cancer, the overall complication rate was low at 10.3%, with the majority being minor complications.

This series reported the lowest incidence of complications in the international literature, highlighting the safety of the procedure, with no significant difference in complication rates between prophylactic and therapeutic dissection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radical open inguinal lymphadenectomy for penile carcinoma: surgical technique, early complications and late outcomes. Koifman, L., Hampl, D., Koifman, N., et al.[2014]

Implementing a new grossing protocol that requires the total submission of lymph node (LN) packets significantly increased the number of LNs identified in patients undergoing radical prostatectomy (RP) and radical cystectomy (RC), with mean counts rising from 8.7 to 14.1 for RP and from 15.9 to 25.2 for RC.

This new method not only improved LN detection but also required more paraffin blocks for processing, indicating a more thorough examination of lymphatic tissue, which could enhance prognostic and therapeutic outcomes in bladder and prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete Tissue Submission to Increase Lymph Node Detection in Pelvic Lymph Node Packets Submitted for Patients Undergoing Radical Prostatectomy and Radical Cystectomy. Rais-Bahrami, S., Tracht, JP., McIntosh, ER., et al.[2017]

In a study of 85 patients who underwent laparoscopic pelvic lymph node dissection, 14% experienced major complications, with CT scans identifying issues in 7 out of 8 cases, highlighting the importance of imaging in post-operative care.

Complications included small-bowel obstruction, hematomas, urinary ascites, and lymphoceles, indicating that while laparoscopic dissection is a minimally invasive option, it can still lead to significant risks that require careful monitoring and recognition of CT findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications after laparoscopic pelvic lymphadenectomy: CT diagnosis. Chow, CC., Daly, BD., Burney, TL., et al.[2016]

Pelvic lymph node dissection is crucial for accurately staging lymph node involvement in prostate and bladder cancer, providing important prognostic information despite advances in imaging techniques.

While some early-stage prostate cancer patients may not require a lymphadenectomy due to low probability of positive lymph nodes, it is essential in bladder cancer due to a significant incidence (about 25%) of unsuspected nodal disease at surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of pelvic lymphadenectomy in the management of prostate and bladder cancer. Woods, ME., Ouwenga, M., Quek, ML.[2018]

Only 24.7% of nonmetastatic penile cancer patients received inguinal lymph node dissection (ILND), indicating low adherence to treatment guidelines, which did not improve over time.

ILND was associated with significantly lower cancer-specific mortality (CSM) in patients with N1, N2, and N3 stages of the disease, suggesting its efficacy in improving survival outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to guideline recommendations for lymph node dissection in squamous cell carcinoma of the penis: Effect on survival and complication rates. Mistretta, FA., Mazzone, E., Palumbo, C., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-neoplasm-metastasis-3-2022-d9266

Surgical Guidance Technology for Urologic Cancer Surgery Research shows that pelvic lymph node dissection, a part of the treatment, is effective in accurately staging prostate and bladder cancer, and can have a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11369446/

Pelvic Lymph Node Dissection: A Comparison Among ... This study aims to compare the outcomes of PLND between extraperitoneal single-port (SP eRARP) and transperitoneal multiport (MP tRARP) robotic-assisted ...

3. researchgate.net researchgate.net/publication/362461788_The_future_of_pelvic_lymph_node_dissection_for_urological_malignancies

The future of pelvic lymph node dissection for urological ... Using 3D Slicer software, Regions of Interest (ROI) were delineated on enhanced venous phase CT images, analyzing 302 positive and 391 negative lymph nodes.

4. nature.com nature.com/articles/s41585-025-01098-4

Optimizing local control in the surgical management of ... This Review highlights crucial advancements and promising future developments in the use of radical cystectomy to achieve local cancer control ...

5. tau.amegroups.org tau.amegroups.org/article/view/15255/html

Robotic inguinal lymphadenectomy for penile cancer A laparoendoscopic inguinal lymphadenectomy has been developed as a new approach to offer potentially curative lymph node resection while minimizing morbidity.

6. imrpress.com imrpress.com/journal/CEOG/50/6/10.31083/j.ceog5006123/htm

Robotic Pelvic Lymphadenectomy in Gynecological and ... Robotic approach to PLND is safe and efficient and can be potentially used for cervical, endometrial, prostate, and bladder cancers.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/ases.13274

Standardization of robot‐assisted pelvic lymph node ... In this project, we attempted to clarify a shared understanding of pelvic anatomy through cross-disciplinary discussions.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40294214/

Pelvic Lymph Node Dissection in Prostate Cancer A Multicentric Longitudinal Study Assessing Oncological Outcomes in Patients With Prostate Cancer Undergoing Pelvic Lymph Node Dissection vs Radical ...

9. bmcurol.biomedcentral.com bmcurol.biomedcentral.com/articles/10.1186/s12894-024-01448-1

Extended pelvic lymph node dissection during robotic ... The study indicates that antegrade and retrograde en-bloc extended pelvic lymph node dissection (ePLND) have comparable surgical and oncologic outcomes.