Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

MSOT

Jutten

van Leeuwen

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.

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).

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

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

Age, sex, BMI, history and morbidity, localization and extent of primary tumor, baseline blood count/liver and kidney function

University Medical Center Groningen

The EUNASS Study Questionnaire is an electronic questionnaire (using the Qualtrics programme) designed to assess management after diagnosis of melanoma and during follow-up, health status, fear of melanoma recurrence, melanoma-specific supportive care needs, sun protection behaviour, views and habits about SSE and standard socio-demographic details.

A qualitative researcher will undertake 25-30 semi-structured interviews with participants who have volunteered their contact details in the final section of the EUNASS Study Questionnaire. A purposive sampling approach will be taken for participant recruitment to this part of the study.

Questionnaire

Rubeta Matin

This is a prospective, multi-centred cohort study whereby the EUNASS Study questionnaire will be administered electronically to identify needs of melanoma survivors, the extent to which these needs are being met, and identify areas which have the greatest need for development. It will also evaluate behaviour in relation to sun protection and skin self-examination (SSE). It will be a self-completed questionnaire.

Qualitative work using semi-structured interviews will explore the needs of melanoma survivors in greater depth, will present examples of potential interventions to improve SSE and explore factors that determine the likelihood of engaging in an intervention which can address unmet needs, such as improving SSE. Taken together, the data will provide the evidence base to inform the development of an intervention to improve SSE, which can subsequently be tested in secondary care services.

Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sentinel Lymph Node Detection in Patients With Stage Ib-III Melanoma Using MSOT and ICG	NCT05467137	Melanoma, Stage... Melanoma, Stage... Melanoma Stage ...	MSOT	18 Years -	University Medical Center Groningen
Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors	NCT04675346	Melanoma, Stage... Melanoma Stage ... Melanoma, Stage...	Questionnaire	18 Years - 80 Years	Oxford University Hospitals NHS Trust
Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors	NCT04675346	Melanoma, Stage... Melanoma Stage ... Melanoma, Stage...	Questionnaire	18 Years - 80 Years	Oxford University Hospitals NHS Trust
Sentinel Lymph Node Detection in Patients With Stage Ib-III Melanoma Using MSOT and ICG	NCT05467137	Melanoma, Stage... Melanoma, Stage... Melanoma Stage ...	MSOT	18 Years -	University Medical Center Groningen

Spots Global Cancer Trial Database for melanoma, stage i