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

Micronutrients

All Drugs and Chemicals

Iron

Patients with melanoma of the extremities included in the protocol. Preoperative, patients will receive two MRI-scans and a magnetic tracer injection at the primary tumor site. During surgery, SLNs will be detected using two types of magnetometers (SentiMag® \& DiffMag) in combination with Magtrace®, in addition to the standard procedure.

In addition to the standard procedure, SLNs will be detected using two types of magnetometers (SentiMag® \& DiffMag) in combination with SPIO particles (Magtrace®).

Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMag

Anke Christenhusz, MSc

Lejla Alic, PhD

Anneriet Dassen

Daniëlle de Leeuw

Anneriet Dassen, PhD

The sentinel lymph nodes (SLNs) are the first lymph nodes (LNs) to drain the tumor site and therefore the first LNs to bare metastases. Hence the importance to investigate these LNs for the best treatment strategy. Current-standard-of-care for melanoma patients with a melanoma stage of pT1b or higher, involve a surgical procedure, referred to as SLN biopsy (SLNB). The SLNB procedure involves a combined detection procedure using a radio-active tracer and blue dye followed by surgical dissection and evaluation of the LNs at the histopathology department. Due to the use of radioisotopes, this procedure suffers from several disadvantages such as limited availability, strict rules and regulations, degradation time in patient and radioactive load for user and patient.

To overcome the limitations of a radioactive tracer, a magnetic SLNB was developed which is facilitated by super paramagnetic iron-oxide (SPIO) nanoparticles. This potentially offers numerous benefits making surgery planning more flexible: no exposure to radiation, easy accessibility of the tracer, long shelf life and long half time in the patient. However, the currently available magnetometer for intraoperative detection of SPIO-enhanced LNs is hampered by a relatively low detection depth, biological noise, and effects of surgical equipment. Therefore, surgeons need to switch to plastic or carbon equipment and the system needs to be balanced prior to each measurement, which increases the surgery time.

A new and effective way to localize SPIOs is differential magnetometry (DiffMag). This patented detection principle, developed by MD\&I group at University of Twente (UT), utilizes the nonlinear magnetic response of nanoparticles. An additional advantage of SPIOs is their visibility on MRI, which could provide mapping the SLNs preoperatively. Especially in patients with melanomas on the abdomen or back this would be very useful to see which lymph node stations are connected to the melanoma. In addition, studies have shown that SPIOs are absorbed into lymph nodes in different ways, depending on the presence of metastases. SPIO-enhanced MR lymphography could therefore provide an opportunity for a non-invasive preoperative assessment of nodal status.

In this pilot study the investigators want to evaluate the clinical use of the DiffMag handheld probe. Moreover, the investigators want to map the lymph nodes (metastases) preoperatively using MR lymphography.

MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients

MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients Measured With DiffMag

Determining the feasibility of SLN detection/localization in melanoma patients using a magnetic tracer (Magtrace®) and hand-held magnetometer DiffMag.

Determining the feasibility of SLN detection/localization in melanoma patients using a magnetic tracer (Magtrace®) and hand-held magnetometer Sentimag.

Determining the feasibility of LN mapping with preoperative SPIO-enhanced MR lymphography and examining the use of SPIO-enhanced MR lymphography for LN staging.

University of Twente

PhD student / coordinating investigator

Breast Neoplasms

Breast Diseases

The day of the surgery 1 ml of green indocyanine colorant will be applicated periareolar. After 5 minutes the lymph node will be detected and extracted

Application of green indocyanine colorant

Application of a periareolar injectionof TEchnetium 99 in order to detect the axillary lymph node

Technetium99

Sandra Lopez gordo

The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.

In the operating room 1 ml of indocyaninge grenn will be injectec periareolar . After 5 minutes the lymph node will be detected and extracted. The comparison between the lymph nodes detected with Technetium 99 and indocyanine green will be analysed.

Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer

Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast.

With REDCap program this study will allow to participated diferents institutions (Hospitals) in Spain

Number of lymph node detected with Indocyanine green and number of lymph node detected iwth techetium 99. Scale of numbers

assess whether there are differences in affected lymph nodes detected with indocyanine green or technetium 99 Number of possitive lymph nodes iwh indocyanine green and with technetium 99

Time in minutes from skin incision to lymp node removal.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients	NCT05569707	Melanoma (Skin)	Magnetic sentin...	18 Years -	University of Twente
Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer	NCT06378944	Breast Cancer	Application of ... Technetium99	18 Years - 120 Years	Omphis Foundation
Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer	NCT06378944	Breast Cancer	Application of ... Technetium99	18 Years - 120 Years	Omphis Foundation

Spots Global Cancer Trial Database for lymph node detection