The Use of Magtrace®/Sentimag® in Sentinel Node Biopsy for Malignant Melanoma. The Magmen Study.

Summary

To evaluate the use of superparamagnetic iron oxide (Magtrace®) as a tracer in sentinel node biopsy in malignant melanoma of the extremities, and to evaluate the possible role of Magtrace®-MRI for staging.

Primary objective:

• To evaluate if Magtrace®/Sentimag® can be used to identify SN in malignant melanoma with the same diagnostically reliability as the currently used method of Technetium 99m and Patent blue.

Secondary objectives:

• To evaluate if Magtrace®-MRI can predict sentinel node status in melanoma. This is a feasibility phase I, interventional single arm study. All patients included in the study will receive the same management.

20 patients will be included in the study. An enrollment time of 6-12 months is expected.

Primary endpoint • To determine the detection rate of Magtrace®/Sentimag® in comparison to SNB using technetium and blue dye in patients with malignant melanoma of the extremities.

Secondary endpoint

• To evaluate Magtrace®-MRI sensitivity and specificity as a preoperative tool for staging in malignant melanoma.

Conditions

• Melanoma
• Sentinel Lymph Node

Interventions

DEVICE

SLN Biopsy with Magtrace®/Sentimag®

Identification of SLN by means of Magtrace®/Sentimag® and SPIO-MRI

Sponsors & Collaborators

• Sahlgrenska University Hospital

  lead OTHER

Principal Investigators

• Dimitrios Katsarelias, MD,Phd · Sahlgrenska University Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2020-09-30

Completion

2020-09-30

Countries

• Sweden

Study Locations