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

July 25, 2024 updated by: The Netherlands Cancer Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Men >18 yrs with primary diagnosed prostate cancer eligible for robot assisted radical prostatectomy and lymph node dissection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of this intraoperative visualisation technique
Time Frame: During surgery
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
Time Frame: During surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Henk van der Poel, Prof. MD, NKI-AvL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

April 25, 2024

Study Completion (Actual)

July 24, 2024

Study Registration Dates

First Submitted

November 3, 2021

First Submitted That Met QC Criteria

November 3, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N21SPL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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