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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "All participants will undergo lymph node mapping with Magtrace, and Sentinel Lymph Node Biopsy undertaken and nodes localised with the Sentimag system, A sentimag count will be recorded for each node removed."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with breast cancer having surgery that keeps part of the breast and uses Magtrace to help find lymph nodes for testing. It checks how often skin color changes happen and how well Magtrace helps find sentinel lymph nodes, the first nodes cancer may spread to. Patients will report how skin color changes affect them.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are willing and able to give informed consent, meaning you understand the study and agree to join.
  • Are age 18 or older when you agree to join.
  • Plan to have surgery that keeps part of the breast, such as a lumpectomy, and a sentinel lymph node biopsy using Magtrace. This biopsy removes lymph nodes to check for cancer.

Who can't join

  • Are pregnant or breastfeeding.
  • Have had radiation treatment to the breast being treated.
  • Have signs on an exam or scan that cancer has spread, including lymph nodes that feel abnormal or enlarged.
  • Have had a Feraheme (ferumoxytol) injection in the past 6 months.
  • Have an allergy or cannot tolerate iron, dextran compounds, or Magtrace.
  • Have a disease that causes too much iron to build up in the body.
  • Have breast skin color changes, such as a tattoo, birthmark, tan, or rash, that the study doctor thinks could affect the results, or plan to get a breast tattoo after surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

NC

  • UNC, Lineberger Comprehensive Cancer Center · Chapel Hill, NC 27599Kristalyn Gallagher · Study contactMore trials in Chapel Hill

VA