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Completed

NCT Number: NCT05120973

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multispectral Imaging

Procedure

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

fluorescence for lymphatic mapping

Procedure

Indocyanine green injected in abdominal wall

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

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

Acronym: SPLIT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 16, 2021
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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