A Prospective Open Label Study of Patient Reported Outcome Measures and Efficacy Following the Use of 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients Undergoing Lumpectomy
Endomagnetics Ltd.
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.
Description
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node (SLN) detection rate in patients who have received 1ml 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 utilising BREAST-Q. Baseline assessment using BREAST-Q will performed. A key secondary objective is to demonstrate non-inferiority of sentinel lymph node (SLN) detection rate with Magtrace compared to the American Society of B…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Locations (2)
- UNC, Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
- VCU Massey Comprehensive Cancer CenterRichmond, Virginia