Exploring an alternative pre-operative sentinel lymph node mapping method using a Magnetic tracer and MRI for potential use in melanoma patients: Imaging subprotocol in healthy participants

Exploring an alternative pre-operative sentinel lymph node mapping method using a Magnetic tracer and MRI for potential use in melanoma patients: Imaging subprotocol in healthy participants - TRACIE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49990

Enrollment

Registered

2021-07-26

Start date

2021-09-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma skin cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Dosages of Magtrace® (ml), massage duration (minutes), route of administration and MRI settings (sequences) will be defined stepwise. Time of lymphatic SPIO uptake and appearance of LNs will be defined for different injection regions.	—

Countries

Netherlands

Outcome results