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

NCT ID: NCT05054062

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2021-08-20

Brief 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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy participants

Group Type: EXPERIMENTAL

Sentinel node mapping using MRI

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Sentinel node mapping using MRI

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zuyderland Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

James van Bastelaar

Head of department of Surgery (Surgical Oncologist)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zuyderland Medical Center

Sittard, Limburg, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 36241982 (View on PubMed)

Other Identifiers

METCZ20210103

Identifier Type: -

Identifier Source: org_study_id