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

Melanoma Clinical Trial

— TRACIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05054062
• Other study ID #: METCZ20210103
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 20, 2021

Study information

• Verified date: September 2022
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy participants;
• Participants should be =18 years of age at the time of consent;
• Participants should be willing to provide informed consent.

Exclusion Criteria:

• Known intolerance/hypersensitivity to iron, dextran compounds or Magtrace® itself;
• Standard MRI exclusion criteria:
• Implantable (electrical) devices (e.g. pacemaker, cochlear implants, neurostimulator);
• Any other metal implants;
• Claustrophobia;
• MR-incompatible prosthetic heart valves;
• Tattoos inked with metallic dye.
• Participants who refuse to provide informed consent.

Related Conditions & MeSH terms

• Melanoma

Intervention

Diagnostic Test:
• Sentinel node mapping using MRI
Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Center	Sittard	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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