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

Prostate Cancer Clinical Trial

— SPLIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05120973
• Other study ID #: N21SPL
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: November 2025

Study information

• Verified date: September 2023
• Source: The Netherlands Cancer Institute
• Contact: Henk van der Poel, Prof. MD
• Phone: 0205129111
• Email: h.vd.poel[@]nki.nl
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• multispectral imaging
Sentinel node biopsy with Indocyanine Green -Technetium - Nanocolloid + fluorescein
• fluorescence for lymphatic mapping
Indocyanine green injected in abdominal wall

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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