Clinical trial NCT05054062: Sentinel Lymph Node Mapping Using Magtrace and MRI in Healthy Subjects for Potential Use in Melanoma Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: Magnetic tracer
Sentinel lymph node
Melanoma
MRI
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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;
* 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.

Primary outcomes:
measure: SPIO dosage in milliliters
timeFrame: Three weeks
measure: Massage duration in seconds
timeFrame: Three weeks
measure: Time to artefact appearance in minutes
timeFrame: Three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: Zuyderland Medical Center
state: Limburg
Study officials:
References:
citation: 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.