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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy participants | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel node mapping using MRI | Diagnostic Test | Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| SPIO dosage in milliliters | SPIO dosage in milliliters will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects. | Three weeks |
| Massage duration in seconds | Massage duration in seconds will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects. | Three weeks |
| Time to artefact appearance in minutes | Time to artefact appearance in minutes will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects. | Three weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuyderland Medical Center | Sittard | Limburg | 6162BG | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36241982 | Derived | Aldenhoven L, Frotscher C, Korver-Steeman R, Martens MH, Kuburic D, Janssen A, Beets GL, van Bastelaar J. Sentinel lymph node mapping with superparamagnetic iron oxide for melanoma: a pilot study in healthy participants to establish an optimal MRI workflow protocol. BMC Cancer. 2022 Oct 14;22(1):1062. doi: 10.1186/s12885-022-10146-w. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |