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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment 3D Slicer, SlicerIGT, Monaco, Urologic Lymphadenectomy, Pelvic lymphadenectomy, Groin dissection, Lymph node dissection 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 positive impact on cancer control. It is considered the most accurate method for staging lymph node involvement, which is crucial for determining the extent of cancer and planning further treatment. ^{1 2 3 4 5}

Is surgical guidance technology for urologic cancer surgery safe?

Lymph node dissection, a part of urologic cancer surgery, can have complications like lymphocele (fluid collection), blood clots, and nerve or blood vessel injuries, but improvements in surgical techniques have reduced these risks. Laparoscopic methods, which are less invasive, show a lower complication rate and quicker recovery compared to open surgery. ^{2 6 7 8 9}

How is urologic lymphadenectomy different from other treatments for urologic cancer?

Urologic lymphadenectomy, especially when performed using robotic or laparoscopic techniques, is a minimally invasive surgical approach that allows for precise removal of lymph nodes with potentially fewer complications and quicker recovery compared to traditional open surgery. This method is particularly useful for staging and treating various urologic cancers, offering a balance between effectiveness and reduced patient burden. ^{2 10 11 12 13}

Research Team

Matthew Mossanen, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The role of pelvic lymphadenectomy in the management of prostate and bladder cancer. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic pelvic lymph node dissection: a review of 103 consecutive cases. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Lymphadenectomy for bladder cancer: indications and controversies. [2011]

5. United States 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. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Radical open inguinal lymphadenectomy for penile carcinoma: surgical technique, early complications and late outcomes. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Complications of lymphadenectomy in urologic surgery. [2011]

8. United States 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. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Standardized comparison of robot-assisted limited and extended pelvic lymphadenectomy for prostate cancer. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A nomogram to predict the duration of drainage in patients with penile cancer treated with inguinal lymph node dissection. [2011]

11. Italy pubmed.ncbi.nlm.nih.gov

Robot assisted lymphadenectomy in urology: pelvic, retroperitoneal and inguinal. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of minimally invasive versus open lymphadenectomy in urological cancers. [2014]

13. United States pubmed.ncbi.nlm.nih.gov

Complications after laparoscopic pelvic lymphadenectomy: CT diagnosis. [2016]