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

Breast Neoplasms

All Drugs and Chemicals

Immunomodulating Agents

Participants with a suspicious finding at breast ultrasonography (BI-RADS 4 suspicious abnormality; BI-RADS 5, highly suggestive for malignancy) who are scheduled for ultrasound-guided breast biopsy will undergo MSOT imaging of the suspicious breast tumor detected with ultrasound imaging and any additional lesion present in either breast before undergoing ultrasound-guided breast biopsy as the standard of care. We will evaluate MSOT in 10 patients from the Melanoma Surgical Oncology Clinics (Dr. Ariyan, Co-I) with pathologically confirmed ITM following physical exam and biopsy. We will also evaluate MSOT in five melanoma patients with pathologically confirmed IT metastases scheduled for neoadjuvant immunotherapy prior to surgical resection.

Each participants will undergo MSOT imaging of the suspicious breast tumor detected with ultrasound imaging and any additional lesion present in either breast before undergoing ultrasound-guided breast biopsy as the standard of care. Melanoma participants with pathologically confirmed ITM will undergo MSOT imaging following physical exam and biopsy. Melanoma patients receiving immunotherapy will undergo MSOT imaging prior to and following immunotherapy.

Multispectral Optoacoustic Tomography Imaging

Jan Grimm, MD, PhD

Katja Pinker-Domenig, MD, PhD

Vasilis Ntziachristos, PhD

Participants in this study will have Multispectral Optoacoustic Tomography/MSOT imaging of both breasts immediately before their ultrasound-guided breast biopsy procedure begins. After the MSO imaging is completed, participation in the study will end.

A Study of Tumor Imaging With Multispectral Optoacoustic Tomography

A Feasibility Study of Multispectral Optoacoustic Tomography (MSOT) Imaging in Patients With Tumors

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary goal of this study is to evaluate the feasibility of MSOT for breast cancer and melanoma detection. Feasibility is defined as the ability of the method to visualize tumors that have been identified with standard methods (ultrasound, mammography, MRI), and the ability to obtain oxygenation maps of benign and malignant breast and melanoma tumors. MSOT will be considered feasible if it is able to visualize tumors and obtain oxygenation maps in at least 14 patients out of 20

Memorial Sloan Kettering Cancer Center

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
A Study of Tumor Imaging With Multispectral Optoacoustic Tomography	NCT05488483	Breast Cancer Melanoma	Multispectral O...	18 Years -	Memorial Sloan Kettering Cancer Center
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
A Study of Tumor Imaging With Multispectral Optoacoustic Tomography	NCT05488483	Breast Cancer Melanoma	Multispectral O...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for msot

Every month we try and update this database with for msot cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for msot

Every month we try and update this database with for msot cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for msot cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.