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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-07-24

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.

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Tc-ICG in the prostate (SN procedure) and fluorescein unlilateral in leg or abdominal wall

multispectral imaging

Intervention Type PROCEDURE

Sentinel node biopsy with Indocyanine Green -Technetium - Nanocolloid + fluorescein

B

Free ICG bilateral in the abdominal wall

fluorescence for lymphatic mapping

Intervention Type PROCEDURE

Indocyanine green injected in abdominal wall

Interventions

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multispectral imaging

Sentinel node biopsy with Indocyanine Green -Technetium - Nanocolloid + fluorescein

Intervention Type PROCEDURE

fluorescence for lymphatic mapping

Indocyanine green injected in abdominal wall

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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 Briganti 2012 nomogram (\> 7%)
* Scheduled for surgical (laparoscopic) prostatectomy including ePLND-
* Suitable for RP and ePLND, as per institutional guidelines

* 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 Briganti 2012 nomogram (\> 15%)
* Scheduled for surgical (laparoscopic) prostatectomy including ePLND-
* Suitable for RP and ePLND, as per institutional guidelines

Exclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No