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

Sponsor

University Medical Center Groningen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05467137

Collaborator

(none)

Enrollment

Arm

5.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma, Stage I Melanoma, Stage II Melanoma Stage III	Device: MSOT	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Standard of care + MSOT

Standard of care + MSOT

Device: MSOT

MSOT imaging (after ICG injection)

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Center Groningen

Investigators

Principal Investigator: van Leeuwen, University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT05467137

Other Study ID Numbers:

202100685

First Posted:

Jul 20, 2022

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Jul 20, 2022