Introduction:

Pelvic lymph node dissection (PLND) is a fundamental component in the management of muscle-invasive bladder cancer (MIBC). Currently, there are no available tools to intra-operatively reliably target and identify lymph nodes which may have metastasis; therefore, a template-based PLND of lymph node landing zones must be performed. Prior studies in animal models have mapped lymph node drainage from the bladder using fluorescent molecules. Hexaminolevulinate HCl dye is a candidate for the proposed application In this study, given its fluorescent properties and ability to differentiate between normal urothelial cells and urothelial carcinoma.

Methods:

This is an investigator-initiated, single-institution, single-arm prospective study to determine the feasibility and safety of Hexaminolevulinate HCl administration into the bladder prior to robotic assisted radical cystectomy (RARC) and assessing for the presence of fluorescence in the lymph node regions and at the surgical margin via blue light laparoscopy. The study will recruit 10 patients with MIBC and either imaging-confirmed cN1 disease or higher risk for nodal metastasis with > cT3 disease. Patients will receive intravesical instillation of Hexaminolevulinate HCl prior to the standard of care: RARC and PLND. The surgeon’s subjective assessment of fluorescence during blue light intra-abdominal laparoscopy will be recorded. The obturator node packet will undergo: 1) standard pathologic analysis for nodal metastasis, 2) analysis under epifluorescent microscopy to assess for microscopic fluorescence and 3) ex vivo staining in Hexaminolevulinate HCl dye followed by epifluorescent microscopy. Enrollment opened on December 1, 2022.

Results:

Conclusion:

Funding: Photocure, Inc.