The primary objective of this study, including healthy subjects, is to develop a pre-operative MRI protocol for the localization of SLNs in melanoma patients. Acquired knowledge will serve to design a feasibility study, including a larger group of…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dosages of Magtrace® (ml), massage duration (minutes), route of administration
and MRI settings (sequences) will be defined stepwise. Time of lymphatic SPIO
uptake and appearance of LNs will be defined for different injection regions.
Secondary outcome
NA
Background summary
Sentinel lymph node biopsy 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.
Subsequently, a lymphoscintigraphy (LS) and single-photon emission computed
tomography/computed tomography (SPECT/CT) will be performed. Intra-operatively,
Blue dye (BD) will be injected to improve the visualization of the lymphatic
tract.
Superparamagnetic iron oxide (SPIO) is a novel technique using a magnetic
tracer (Magtrace® (Endomagnetics Ltd.)) and several studies showed that SPIO is
non-inferior to dual tracing with 99mTc and BD in breast cancer patients. SPIO
is expected to be non-inferior to dual tracing with 99mTc and BD in melanoma
patients. However, further research is needed to demonstrate the use of
Magtrace in pre-operative MRI scanning. Magnetic tracers have an extended time
span in contrast to isotopes, which provides more opportunities in scheduling
scans and might therefore optimize the pre-operative care pathway.
Additionally, it is a non-radioactive alternative which is in favor of both
patients and healthcare personnel.
A pre-operative MRI protocol will be developed by including healthy
participants of the research team in a small study. Injection sites, Magtrace
dosage, massage duration and artefact transformation will be evaluated.
Depending on findings, two or three test days will be scheduled.
Acquired knowledge will serve to design a feasibility study, including a larger
group of melanoma patients.
Study objective
The primary objective of this study, including healthy subjects, is to develop
a pre-operative MRI protocol for the localization of SLNs in melanoma patients.
Acquired knowledge will serve to design a feasibility study, including a larger
group of melanoma patients.
Study design
This small prospective subprotocol study will adopt a step-by-step approach to
develop a pre-operative MRI protocol for the localization of SLNs in melanoma
patients. Testing will be performed according to a predefined protocol,
however, the protocol might be adapted considering findings in first
participants.
Study burden and risks
The aim of the study is to develop a pre-operative MRI protocol, eventually
applicable in melanoma patients to identify SLN prior to SLNB. Magtrace® is
formerly approved and used in breast cancer patients. Except one hospital
visit, no burden and risks are associated with participation.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78112.096.21 |