RECRUITING

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

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 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
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Related Conditions:

Breast Cancer

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Richmond

VCU Massey Comprehensive Cancer Center, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Endomagnetics Ltd.,

Study Record Dates

2028-11