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

Launched by ENDOMAGNETICS LTD. · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial, called "PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients," is exploring how using a special dye called Magtrace during a breast cancer surgery can affect patients. Specifically, the study aims to understand how often patients experience skin discoloration after the procedure and how this impacts their quality of life. The trial will gather information from patients in the U.S. who are undergoing surgery to remove a tumor and have a sentinel lymph node biopsy, which is a way to check for cancer spread.

To participate in this study, patients need to be 18 years or older and willing to give consent. They should be having breast-conserving surgery, like a lumpectomy, and a sentinel lymph node biopsy using Magtrace. However, individuals who are pregnant, have had certain types of previous treatment, or have specific skin conditions may not be eligible. Participants will be monitored for skin changes after the surgery and will provide feedback on how these changes affect them. This trial is not currently recruiting, but it aims to help improve the understanding of treatment outcomes for breast cancer patients.

Gender

ALL

Eligibility criteria

• 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.