NCT03898687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

March 25, 2019

Last Update Submit

October 19, 2020

Conditions

MelanomaSentinel Lymph Node

Keywords

melanomaSentinel nodeSPIO-MRI

Outcome Measures

Primary Outcomes (1)

  • Identification of Sentinel node with Magtrace®/Sentimag®

    More than 95% success rate for identification of the Sentinel node with Magtrace®/Sentimag®

    12 months

Study Arms (1)

MAGMEN arm

OTHER

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®

Interventions

SLN Biopsy with Magtrace®/Sentimag®DEVICE

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

MAGMEN arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A patient meeting ALL of the following criteria is eligible for participation in the study
  • Male or female aged above 18 years.
  • Signed and dated written informed consent before the start of specific protocol procedures.
  • Histologically confirmed melanoma of the extremities that is candidate to wide local excision and sentinel node biopsy (SLNB).
  • ECOG performance status 0-2

You may not qualify if:

  • A patient meeting ANY of the following criteria is not eligible for study participation:
  • Life expectancy of less than 6 months
  • Pregnant or breast-feeding.
  • Body Mass Index (BMI) \> 45
  • Pacemaker or metal implants
  • Claustrophobia
  • Clinically suspect lymph nodes metastasis on palpation
  • Iron overload disease
  • Known hypersensitivity to iron or dextran compounds
  • Inability to understand given information and give informed consent or undergo study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dimitrios Katsarelias, MD,Phd

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 25, 2019

First Posted

April 2, 2019

Study Start

March 1, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)