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MeMaLoc: Magnetic Marker Localization for Melanoma Surgery. A feasibility study.

MeMaLoc: Magnetic Marker Localization for Melanoma Surgery. A feasibility study. - MeMaLoc-1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42850
Enrollment
30
Registered
2016-11-24
Start date
2016-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melanoma skin cancer

Interventions

Subjects will receive an ultrasound-guided placement of a magnetic marker (the MaMaLoc marker) in a lesion that will be later removed during surgery. This is either a locoregional or distal non-palp
Melanoma
Non-palpable
Surgery

Sponsors

Nederlands Kanker Instituut
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. 18 years or older 2. Signed informed consent 3. Scheduled for either * Surgery of clinically occult (sub)cutaneous or muscular melanoma lesion(s) (group 1) OR * Complete Lymph Node Dissection of inguinal or axillary region (group 2)

Exclusion criteria

Exclusion criteria: - MRI necessary in period between placement of magnetic marker and surgery

Design outcomes

Primary

MeasureTime frame
1. Retrieval rate: in how many cases is the surgeon able to adequately localise and remove the marked lesion using the magnetic detection technology.

Secondary

MeasureTime frame
2. Radiologist satisfaction: to what extent is placing the experimental magnetic marker comparable to the current clinical practice, what is different and what are (dis)advantages? 3. Surgeon satisfaction: how does intraoperative localisation using the magnetic technology compare to the current clinical practice, what is different and what are (dis)advantages?

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)