PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients

NCT06610539 | Recruiting

• 1 other identifier: US-004
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 2

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

Keywords

Magtrace; Sentinel Lymph Node Biopsy

Outcome Measures

Primary Outcomes (1)

• Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample

  Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample

  post-op to 24 month follow-up

Secondary Outcomes (9)

• Change in BREAST-Q score from post-operative visit through to resolution of skin discoloration or through 24 months, whichever is earlier, in the subgroup of patients with discoloration. 7 core scales will be used.

  Baseline to 24 month follow-up

• Change in BREAST-Q score from pre-operative visit to post-operative visit in patients with and without skin discoloration at the post-op follow-up visit.

  Pre-op to Post-Op

• Duration of discoloration over time post-op to resolution of discoloration or 24 month follow-up

  Post-op to 24 month follow-up

• Intensity of discoloration (absolute color and contrast to normal breast color) over time post-op to resolution of discoloration or 24 month follow-up

  Post-Op to 24 month follow-up

• Severity of discoloration over time post-op to resolution of discoloration or 24 month follow-up as assessed by height and width measurement

  Post-Op to 24 month follow-up

Other Outcomes (1)

• Overall SLN detection rate (proportion of patients with successful SLN detection using Magtrace)

  Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects considered for enrollment will be at least 18 years old at the time of consent, and: a) due to undergo planned breast conserving surgery (for example lumpectomy or partial mastectomy) and SLNB with Magtrace b) meet all other inclusion and no exclusion criteria

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endomagnetics Ltd.: lead
• Endomagnetics Inc: collaborator

Study Sites (2)

UNC, Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Vicky Crawford

CONTACT

+441223652617; vcrawford@endomag.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: April 22, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)