Sentinel Lymph Node Mapping Using Magtrace and MRI in Healthy Subjects for Potential Use in Melanoma Patients (TRACIE)

September 5, 2022 updated by: James van Bastelaar, Zuyderland Medisch Centrum

Sentinel Lymph Node Mapping With Superparamagnetic Iron Oxide for Melanoma: a Pilot Study in Healthy Participants to Establish an Optimal MRI Workflow Protocol

Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique, is associated with disadvantages as radiation exposure for both patients and health care personnel and logistic challenges, because of time constraints due to short half-live time of 99mTc.

Superparamagnetic iron oxide (SPIO) is novel, non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) and several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative Magnetic Resonance Imaging (MRI) scanning. Guidance on pre-operative MRI use is rather limited, though fundamental in the intended research process.

Hence, the aim of this subprotocol study, which includes healthy subjects, is to develop a pre-operative MRI protocol for melanoma patients. The acquired knowledge will be used to design a feasibility study, including a larger group of melanoma patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Sittard, Limburg, Netherlands, 6162BG
        • Zuyderland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy participants;
  • Participants should be ≥18 years of age at the time of consent;
  • Participants should be willing to provide informed consent.

Exclusion Criteria:

  • Known intolerance/hypersensitivity to iron, dextran compounds or Magtrace® itself;
  • Standard MRI exclusion criteria:
  • Implantable (electrical) devices (e.g. pacemaker, cochlear implants, neurostimulator);
  • Any other metal implants;
  • Claustrophobia;
  • MR-incompatible prosthetic heart valves;
  • Tattoos inked with metallic dye.
  • Participants who refuse to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Healthy participants
Diagnostic test: Sentinel node mapping using MRI
Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPIO dosage in milliliters
Time Frame: Three weeks
SPIO dosage in milliliters will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.
Three weeks
Massage duration in seconds
Time Frame: Three weeks
Massage duration in seconds will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.
Three weeks
Time to artefact appearance in minutes
Time Frame: Three weeks
Time to artefact appearance in minutes will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.
Three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2021

Primary Completion (ACTUAL)

August 20, 2021

Study Completion (ACTUAL)

August 20, 2021

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (ACTUAL)

September 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METCZ20210103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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