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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: multispectral imaging
* Procedure: fluorescence for lymphatic mapping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Group A: Male, aged ≥ 18 years. WHO performance status 0,1, or 2. Written informed consent. Histopathologically confirmed adenocarcinoma of the prostate Increased risk of nodal metastases according to the MSKCC nomogram (> 7%) Scheduled for surgical (laparoscopic) prostatectomy including ePLND- Suitable for RP and ePLND, as per institutional guidelines Exclusion Criteria Group A: Prior abdominal or inguinal surgery (e.g. appendectomy) History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or allergic rhinitis Hyperthyroid or thyroidal adenoma Kidney insufficiency History of oversensitivity to FLUORESCITE composites Patients using beta-blockers Inclusion Criteria Group B: Male, aged ≥ 18 years. WHO performance status 0,1, or 2. Written informed consent. Histopathologically confirmed adenocarcinoma of the prostate Increased risk of nodal metastases according to the MSKCC nomogram (> 7%) Scheduled for surgical (laparoscopic) prostatectomy including ePLND- Suitable for RP and ePLND, as per institutional guidelines Exclusion Criteria Group B: Prior abdominal or inguinal surgery (e.g. appendectomy) History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or aller-gic rhinitis Hyperthyroid or thyroidal adenoma Kidney insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Tc-ICG in the prostate (SN procedure) and fluorescein unlilateral in leg or abdominal wall | Procedure: multispectral imaging<br>* Sentinel node biopsy with Indocyanine Green -Technetium - Nanocolloid + fluorescein<br>|
| B<br>Free ICG bilateral in the abdominal wall | Procedure: fluorescence for lymphatic mapping<br>* Indocyanine green injected in abdominal wall<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of this intraoperative visualisation technique | The ability to visually differentiate the draining lymphatics of the lower limbs and abdominal wall, (LNLower limb/abdominal wall; fluorescein) from the disease associated LNs (LNprostate cancer; ICG-99mTc-nanocolloid) during lymph node dissection | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic localisation | Determine the anatomical relationship between lymphatic tumour spread and the lymphatic drainage profiles of the lower limbs and primary tumour (i.e. prostate) in relation to ePLND template. | During surgery |