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

All patients will undergo lymphatic mapping with SPIO, 99mTc and PB.

Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI

Diagnostic Test: Sentinel node mapping using MRI

James van Bastelaar, MD, PhD

Loeki Aldenhoven, MSc

Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique is associated with disadvantages as radiation exposure for both patients and health care staff and logistic challenges, because of time constraints due to short half-live time of 99mTc.

Superparamagnetic iron oxide (SPIO) is a non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) to identify SLNs. Several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative MRI scanning.

The primary objective of this study is to evaluate the feasibility and diagnostic accuracy of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and single-photon emission computed tomography/computed tomography (SPECT/CT) using 99mTc for identifying SLN status in melanoma patients.

Rationale: Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique is associated with disadvantages as radiation exposure for both patients and health care staff and logistic challenges, because of time constraints due to short half-live time of 99mTc.

Superparamagnetic iron oxide (SPIO) is a non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) to identify SLNs. Several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative MRI scanning.

Objective: The primary objective of this study is to evaluate the feasibility and diagnostic accuracy of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and single-photon emission computed tomography/computed tomography (SPECT/CT) using 99mTc for identifying SLN status in melanoma patients. A secondary objective is to assess the feasibility and diagnostic accuracy of SPIO/magnetometer (Sentimag®, Endomagnetics Ltd.) in comparison with dual trace gold standard (99mTc and PB) in SLN procedures in melanoma patients.

Study design: A prospective single-arm feasibility study will be performed at the department of Surgical oncology at Zuyderland Medical Center Sittard, the Netherlands.

Study population: Adult patients (≥18 years) with primary melanoma stage I-II and an indication for wide local excision (1 cm) and SLN procedure will be included in the study.

Intervention (if applicable): All patients will undergo lymphatic mapping with a SPIO tracer (Magtrace®), 99mTc and PB.

Main study parameters/endpoints: The concordance in SLN detection rate (sensitivity and specificity) of SPIO/MRI and LS and SPECT/CT using 99mTc.

The concordance in SLN detection rate (sensitivity and specificity) of SPIO/magnetometer and the gold standard dual trace technique using 99mTc/Gamma probe and PB. Additionally, the number of post-injection (skin) reactions, complication and adverse events will be noted.

Exploring an Alternative Pre-operative SLN Mapping Method Using a Magnetic Tracer and MRI for Melanoma Patients

Exploring an Alternative Pre-operative Sentinel Lymph Node Mapping Method Using a Magnetic Tracer and MRI for Melanoma Patients

The diagnostic accuracy of SPIO/MRI and LS+SPECT/CT and 99mTc to identify SLN will be expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals. MRI image analyses will be performed by two independent professionals.

The diagnostic accuracy of SPIO/magnetometer and PB, 99mTc and Gamma probe will be expressed as sensitivity and specificity, and positive and negative predictive values, including their 95% exact binomial confidence intervals .

Time/duration of 99mTc injection + LS + SPECT/CT and time/duration of SPIO injection + MRI will be compared

Zuyderland Medisch Centrum

Head of department of Surgery (MD, PhD)

Micronutrients

All Drugs and Chemicals

Iron

Sentinel node mapping using MRI

Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique, is associated with disadvantages as radiation exposure for both patients and health care personnel and logistic challenges, because of time constraints due to short half-live time of 99mTc.

Superparamagnetic iron oxide (SPIO) is novel, non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) and several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative Magnetic Resonance Imaging (MRI) scanning. Guidance on pre-operative MRI use is rather limited, though fundamental in the intended research process.

Hence, the aim of this subprotocol study, which includes healthy subjects, is to develop a pre-operative MRI protocol for melanoma patients. The acquired knowledge will be used to design a feasibility study, including a larger group of melanoma patients.

Sentinel Lymph Node Mapping Using Magtrace and MRI in Healthy Subjects for Potential Use in Melanoma Patients

Sentinel Lymph Node Mapping With Superparamagnetic Iron Oxide for Melanoma: a Pilot Study in Healthy Participants to Establish an Optimal MRI Workflow Protocol

SPIO dosage in milliliters will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.

Massage duration in seconds will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.

Time to artefact appearance in minutes will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.

Head of department of Surgery (Surgical Oncologist)

Breast Neoplasms

Breast Diseases

All prospective patients will receive a MagSeed in the diagnosed breast cancer tumor. In addition, they will receive MagTrace to detect the sentinel lymph node during surgery. Since this is an experimental study, the patients will also be injected with the golden standard of Technetium tracer.

Combining MagSeed and Magtracer to perform a wide local excision breast conserving surgery and sentinel node biopsy.

MagSeed and MagTrace in breast cancer patiënts

Rationale:

In breast cancer, a sentinel node procedure is performed to investigate whether malignant cells have spread to the axillary lymph nodes. This is an important part of determining the stage of breast cancer and the final treatment plan.

A disadvantage of the sentinel node procedure is that it is performed using radioactive tracing with concomitant radiation exposure for the patients and involved health care personnel. In addition, the use of radioactive tracing puts high demands on the logistics in the operation theatre: the capacity of patients that can be treated in one day is limited and the radio-active tracing leads to many time-consuming precautionary measures.

A radiation free alternative would therefore have multiple advantages. Not only with respect to radiation exposure for the patients and health care workers, but also by reducing the waiting time for operation for the patients as it will make the planning of patients for surgery more efficient.

Recently, a radiation free tracer for the sentinel node procedure has become available (Magtrace). This tracer has been tested in small-case studies and is currently used as standard care in several hospitals around the world.

Objective:

The primary objective of this study is to evaluate the diagnostic accuracy of Magtrace in the sentinel node procedure in breast cancer in the Breast Care Centre in Zuyderland Medical Centre; with the ultimate goal to make the sentinel node procedure a radiation free process.

Study design:

A prospective cohort of forty patients with breast cancer and an indication for a sentinel node procedure will be injected with both Technetium (radioisotope) and Magtrace (magnetic). All patients in this study will receive both tracers.

Study population:

Patients of 18 years or older with breast cancer and an indication for a sentinel node procedure will be included. These patients will be recruited by their breast surgeon in the outpatient department of the Breast Care Centre in Zuyderland Medical Centre.

Intervention (if applicable):

Sentinel node procedure using a magnetic tracer next to Technetium.

Main study parameters/endpoints:

The concordance in detection of sentinel nodes by Magtrace and the Technetium tracer, measured by the sensitivity and specificity of Magtrace in detecting sentinel nodes with Technetium tracer as gold standard.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

The goal of this project is evaluating the diagnostic accuracy of Magtrace in the sentinel node procedure. To establish that Magtrace is a non-inferior and a non-radioactive alternative for Technetium with respect to reliability in detecting metastases. The ultimate goal is to make the sentinel node procedure a radiation free process.

Magnetic Tracer in the Sentinel Node Procedure in Breast Cancer: the Non-radioactive Alternative for Radio-isotopes

Number of sentinel lymph nodes detected using MagTrace and Technetium and their concordance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Exploring an Alternative Pre-operative SLN Mapping Method Using a Magnetic Tracer and MRI for Melanoma Patients	NCT05145829	Melanoma	Diagnostic Test...	18 Years -	Zuyderland Medisch Centrum
Exploring an Alternative Pre-operative SLN Mapping Method Using a Magnetic Tracer and MRI for Melanoma Patients	NCT05145829	Melanoma	Diagnostic Test...	18 Years -	Zuyderland Medisch Centrum
Sentinel Lymph Node Mapping Using Magtrace and MRI in Healthy Subjects for Potential Use in Melanoma Patients	NCT05054062	Melanoma	Sentinel node m...	18 Years -	Zuyderland Medisch Centrum
Magnetic Tracer in the Sentinel Node Procedure in Breast Cancer: the Non-radioactive Alternative for Radio-isotopes	NCT05122585	Breast Cancer	MagSeed and Mag...	18 Years -	Zuyderland Medisch Centrum

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