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

NCT05120973 | Completed

• 1 other identifier: N21SPL
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anatomic localisation

  During surgery

Study Arms (2)

A

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

Procedure: multispectral imaging

B

Free ICG bilateral in the abdominal wall

Procedure: fluorescence for lymphatic mapping

Interventions

multispectral imaging PROCEDURE

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

A

fluorescence for lymphatic mapping PROCEDURE

Indocyanine green injected in abdominal wall

B

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: men with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Prior abdominal or inguinal surgery (e.g. appendectomy)
• History of allergy to iodine, food or medicinal induced urticaria, asthma, eczema, or allergic rhinitis

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36401635 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fluorescence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Luminescence; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena

Study Officials

• Henk van der Poel, Prof. MD

  NKI-AvL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 16, 2021
• Study Start: November 1, 2021
• Primary Completion: April 25, 2024
• Study Completion: July 24, 2024
• Last Updated: July 29, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)