MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients

Trial Title: MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients

NCT ID: NCT05569707

Condition: Melanoma (Skin)

Conditions: Official terms:
Melanoma

Conditions: Keywords:
Magnetic sentinel lymph node biopsy (SLNB)
Lymph node detection
Lymph node staging
MR lymphography
Super paramagnetic iron-oxide (SPIO) nanoparticles

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMag
Description: In addition to the standard procedure, SLNs will be detected using two types of magnetometers (SentiMag® & DiffMag) in combination with SPIO particles (Magtrace®).
Arm group label: MelaDiff

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients with melanoma of the upper or lower extremities scheduled for SLNB; - Willing to & able to write informed consent from the subject prior to participation; - Willing to & capable of following study procedures; - Is older than 18 years; - Speaks and understand the Dutch language Exclusion Criteria: - Intolerance / hypersensitivity to iron or dextran compounds - Pregnant or lactating patients; - Patients having a pacemaker. - Patients non eligible for MRI investigation (pacemakers or other implantable devices in the chest wall and/or lower body, claustrophobic, etc.)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Medisch Spectrum Twente

Address:
City: Enschede
Country: Netherlands

Investigator:
Last name: Anneriet Dassen
Email: Principal Investigator

Facility:
Name: Ziekenhuisgroep Twente (ZGT)

Address:
City: Hengelo
Country: Netherlands

Investigator:
Last name: Daniëlle de Leeuw
Email: Principal Investigator

Start date: January 2023

Completion date: March 2024

Lead sponsor:
Agency: University of Twente
Agency class: Other

Source: University of Twente

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05569707