The Use of Magtrace®/Sentimag® in Sentinel Node Biopsy for Malignant Melanoma. The Magmen Study. (MAGMEN)
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|ClinicalTrials.gov Identifier: NCT03898687|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
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.
• 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.
• 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.
• To evaluate Magtrace®-MRI sensitivity and specificity as a preoperative tool for staging in malignant melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Sentinel Lymph Node||Device: SLN Biopsy with Magtrace®/Sentimag®||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sentinel Node Localisation and Staging With Superparamagnetic Iron Oxide-enhanced MRI and Magtrace®/Sentimag® in Patients With Malignant Melanoma of the Extremities. The MAGMEN Feasibility Study|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||January 31, 2020|
Patients with melanoma of the extremities included in the protocol. SLNB will be performed with the addition of magtrace (SPIO) injection, 0.2 ml around previous scar. The patients will undergo MRI of the involved basin (Axilla-groin)and receive the SpIO injection the day before SLN biopsy. A separate SPIO MRI will be performed before the operation. All patients will receive all 3 methods for SLN identification as described in the protocol.
Device: SLN Biopsy with Magtrace®/Sentimag®
Identification of SLN by means of Magtrace®/Sentimag® and SPIO-MRI
- Identification of Sentinel node with Magtrace®/Sentimag® [ Time Frame: 12 months ]More than 95% success rate for identification of the Sentinel node with Magtrace®/Sentimag®
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898687
|Contact: Dimitrios Katsarelias, MD, Phdemail@example.com|
|Contact: Roger Olofsson-Bagge, MD,PhDfirstname.lastname@example.org|
|Sahlgrenska University Hospital||Recruiting|
|Contact: Dimitrios Katsarelias, MD, PhD email@example.com|
|Principal Investigator:||Dimitrios Katsarelias, MD,Phd||Sahlgrenska University Hospital, Sweden|