Sentinel Lymph Node Detection in Patients With Stage Ib-III Melanoma Using MSOT and ICG (MelanooMSOT)

Sentinel Lymph Node Detection in Patients With Stage Ib-III Melanoma Using MultiSpectral Optoacoustic Tomography (MSOT) and IndoCyanine Green (ICG)

In this study the investigators try to identify the sentinel lymph node in patients with stage Ib-III melanoma in a non-invasive manner without the use of a radioactive tracer by using the new MSOT technology.

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma Stage III; Melanoma, Stage II; Melanoma, Stage I
• Intervention / Treatment: Device: MSOT

Detailed Description

Over the past few decades, melanoma has been one of the fastest-growing cancers and the incidence rate of melanoma is still increasing. Standard treatment for melanoma is wide (re)excision. Sentinel lymph node (SLN) biopsy (SLNB) is recommended for patients with melanoma of AJCC stage pT1b or higher according to Dutch guidelines. SLNB provides essential staging information that impacts on the clinical management of patients with melanoma, and the presence of SLN metastasis indicates a significantly worse prognosis. However, the overall complication rate of SLNB is high.

Currently, lymphoscintigraphy using 99mTc-nanocolloid Technetium-99m-nanocolloïd (Tc99m) is the gold standard to identify the sentinel lymph node. However, there are various disadvantages of using 99mTc-nanocolloidTc99m: the involvement of radioisotopes represents a radioactive burden for patients and caregivers, the lymphoscintigraphic imaging has poor spatial resolution, and the involvement of radioisotopes is expensive and creates logistic challenges. Therefore, in this study the goal is to identify the sentinel lymph node in a non-invasive manner without the use of a radioactive tracer. The investigators try to reach this goal by using the fluorophore dye IndoCyanine Green (ICG) and multispectral optoacoustic imaging (MSOT).

MSOT is a new, but increasingly used, imaging modality that has emerged the field of optical imaging. MSOT is based on a highly powerful pulsed laser in different wavelengths. Photo absorbing molecules absorb laser light in a specific wavelength, undergo thermal expansion and create soundwaves which can be detected by special transducers. The MSOT combines conventional ultrasonography with optoacoustic imaging which gives both anatomical and biological information and is currently available in the University Medical Centre Groningen (UMCG).

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jutten; Phone Number: 0031 50 361 6161; Email: e.jutten@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with grade Ib- III melanoma scheduled for SLNB and/or surgical excision.
• Patients must be > 18 years old and be able to give informed consent.
• Skintype I-IV following Fitzpatrick skin classification (MSOT less reliable in skin types >IV)

Exclusion Criteria:

• Apparent hyperthyroidism or autonomous thyroid adenoma of the thyroid gland
• Prior surgery or radiotherapy on involved lymph nodes / area
• Major surgery within 28 days before tracer administration
• Pregnant or nursing women, fertile women will need a negative pregnancy test prior to inclusion
• History of iodine allergy or anaphylactic reactions to insect bites
• Hypersensitivity to ICG or poorly tolerated ICG in the past
• Unexplained allergic reaction in the past
• Skin type >IV following Fitzpatrick skin classification (MSOT less reliable)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of care + MSOT	Device: MSOT; MSOT imaging (after ICG injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concordance rate of SLNs identified by MSOT imaging and ICG versus the standard of care with 99mTc-nanocolloid Tc99m and lymphoscintigraphic imaging	Through study completion (an average of 1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient characteristics	Age, sex, BMI, history and morbidity, localization and extent of primary tumor, baseline blood count/liver and kidney function	Through study completion (an average of 1 year)

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: van Leeuwen, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 202100685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No