NCT05120973

Multispectral Fluorescence as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies in Prostate Cancer.

MultiSPectral fLuorescence Imaging as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies During Lymph Node Dissections in Prostate Cancer.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multispectral imaging of the lymphatic draining pattern of the tumor and the abdominall wall/lower limb to evaluate technical feasibility to differentiate these patterns and in the future reduce the amount of complications that result from damage to lymphatic structures.

Detailed description

By preventing unnecessary resection of healthy lymphatic tissue during extended lymph node dissections, the investigators will be able to reduce the degree and amount of complications that result from damage to the lymphatic structures. The investigators aim to evaluate the technical feasibility of imaging two different lymphatic drainage profiles, namely that of healthy tissue (i.e. the lower limbs/abdominal wall) and that of the primary tumour (i.e. prostate). To realize the differentiation, real-time multispectral fluorescence imaging of two spectrally different tracers (the lymphangiographic tracer fluorescein (injected in the lower limbs and abdominal wall) and sentinel node (SN) specific tracer Indocyanine Green (ICG)-99mTc-nanocolloid (injected in the tumour, followed by a control lymphoscintigraphy and SPECT/CT)) will allow for multispectral (or multicolor) fluorescence. Complementary to the routine surgical procedure, e.g. radical prostatectomy with extended pelvic lymph node dissection (ePLND), the lymphatic drainage pattern of both the tumour and of healthy tissue, i.e. lower limbs and abdominal wall, will be determined in the surgical field/surgical specimens.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	multispectral imaging	Sentinel node biopsy with Indocyanine Green -Technetium - Nanocolloid + fluorescein
PROCEDURE	fluorescence for lymphatic mapping	Indocyanine green injected in abdominal wall

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-04-25
• Completion: 2024-07-24
• First posted: 2021-11-16
• Last updated: 2024-07-29

Locations

1 site across 1 country: Netherlands