Clinical trial NCT05120973: Multispectral Fluorescence as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies in Prostate Cancer.
Official title: MultiSPectral fLuorescence Imaging as a Tool to Separate Healthy and Disease Related Lymphatic Anatomies During Lymph Node Dissections in Prostate Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men \>18 yrs with primary diagnosed prostate cancer eligible for robot assisted radical prostatectomy and lymph node dissection

Brief 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.

Eligibility criteria: 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 Briganti 2012 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 Briganti 2012 nomogram (\> 15%)
* 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 allergic rhinitis
* Hyperthyroid or thyroidal adenoma
* Kidney insufficiency

Primary outcomes:
measure: Feasibility of this intraoperative visualisation technique
timeFrame: During surgery
Secondary outcomes:
measure: Anatomic localisation
timeFrame: During surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
Study officials:
affiliation: NKI-AvL
name: Henk van der Poel, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.