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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
Sponsor:
Information provided by (Responsible Party):
Dimitrios Katsarelias, Sahlgrenska University Hospital, Sweden

Brief 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.


Condition or disease Intervention/treatment Phase
Melanoma Sentinel Lymph Node Device: SLN Biopsy with Magtrace®/Sentimag® Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Melanoma

Arm Intervention/treatment
MAGMEN arm
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




Primary Outcome Measures :
  1. 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®



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient meeting ALL of the following criteria is eligible for participation in the study

  1. Male or female aged above 18 years.
  2. Signed and dated written informed consent before the start of specific protocol procedures.
  3. Histologically confirmed melanoma of the extremities that is candidate to wide local excision and sentinel node biopsy (SLNB).
  4. ECOG performance status 0-2

Exclusion Criteria:

A patient meeting ANY of the following criteria is not eligible for study participation:

  1. Life expectancy of less than 6 months
  2. Pregnant or breast-feeding.
  3. Body Mass Index (BMI) > 45
  4. Pacemaker or metal implants
  5. Claustrophobia
  6. Clinically suspect lymph nodes metastasis on palpation
  7. Iron overload disease
  8. Known hypersensitivity to iron or dextran compounds
  9. Inability to understand given information and give informed consent or undergo study procedures

Information from the National Library of Medicine

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


Contacts
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Contact: Dimitrios Katsarelias, MD, Phd 0046-0313429735 dimitrios.katsarelias@vgregion.se
Contact: Roger Olofsson-Bagge, MD,PhD roger.olofsson.bagge@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Dimitrios Katsarelias, MD, PhD       dimitrios.katsarelias@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Dimitrios Katsarelias, MD,Phd Sahlgrenska University Hospital, Sweden

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Responsible Party: Dimitrios Katsarelias, Principal investigator, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03898687     History of Changes
Other Study ID Numbers: DNR 947-18
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dimitrios Katsarelias, Sahlgrenska University Hospital, Sweden:
melanoma
Sentinel node
SPIO-MRI

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas