Recruiting

Magtrace

Sponsor:

Endomagnetics Ltd.

Code:

NCT06610539

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures.

Conditions

Breast Cancer

Study ID

NCT06610539

Start date

Apr 22, 2025

Status verified date

Mar, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient is willing and able to give informed consent for participation in the study
  • Patient is aged 18 years or older at the time of consent
  • Patients undergoing planned breast conserving surgery (for example, lumpectomy or partial mastectomy) and SLNB with Magtrace

Exclusion Criteria:

  • The patient is pregnant or lactating
  • The patient has had prior breast radiation to the ipsilateral breast
  • The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
  • The patient has recevied a Feraheme (ferumoxytol) injection within the past 6 months
  • The patient has intolerance or hypersensitivity to iron or dextran compounds or to Magtrace
  • The patient has iron overload disease
  • The patient has discoloration on the breast (such as tattoo, birthmark, tanning, rash etc.), that in the Investigator's opinion, could impact the clinical trial results, specifically the assessment of any skin discoloration, or plans to have a tattoo on the breast post-operatively.

Study Design

Enrollment

184 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample [ Time Frame: post-op to 24 month follow-up ]

Central Contacts and Locations

Central contacts

Vicky Crawford

+441223652617vcrawford@endomag.com

Locations

UNC, Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

More Information

Sponsor

Endomagnetics Ltd.

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • Magtrace
  • Sentinel Lymph Node Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endomagnetics Ltd. on 2026-03-16.