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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Tc-ICG in the prostate (SN procedure) and fluorescein unlilateral in leg or abdominal wall |
| |
| B | Free ICG bilateral in the abdominal wall |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multispectral imaging | Procedure | Sentinel node biopsy with Indocyanine Green -Technetium - Nanocolloid + fluorescein |
|
| 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 |
| 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 |
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Inclusion Criteria Group A:
Exclusion Criteria Group A:
Inclusion Criteria Group B:
Exclusion Criteria Group B:
men with prostate cancer
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Men >18 yrs with primary diagnosed prostate cancer eligible for robot assisted radical prostatectomy and lymph node dissection
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| Name | Affiliation | Role |
|---|---|---|
| Henk van der Poel, Prof. MD | NKI-AvL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute | Amsterdam | 1066 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36401635 | Result | Berrens AC, van Oosterom MN, Slof LJ, van Leeuwen FWB, van der Poel HG, Buckle T. Three-way multiplexing in prostate cancer patients - combining a bimodal sentinel node tracer with multicolor fluorescence imaging. Eur J Nucl Med Mol Imaging. 2023 Mar;50(4):1262-1263. doi: 10.1007/s00259-022-06034-x. Epub 2022 Nov 19. No abstract available. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005453 | Fluorescence |
| ID | Term |
|---|---|
| D049449 | Luminescence |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
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| fluorescence for lymphatic mapping | Procedure | Indocyanine green injected in abdominal wall |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D060328 |
| Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |