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Clinical Trial 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.


Clinical Trial Description

By preventing unnecessary resection of healthy lymphatic tissue during extended lymph node dissections, we will be able to reduce the degree and amount of complications that result from damage to the lymphatic structures. We 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 ac 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05120973
Study type Observational
Source The Netherlands Cancer Institute
Contact Henk van der Poel, Prof. MD
Phone 0205129111
Email [email protected]
Status Not yet recruiting
Phase
Start date November 2021
Completion date November 2024

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