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It is hoped this research will demonstrate that a single dose of MSH2TR is safe and well tolerated. It is also hoped that MSH2TR is an effective method for detecting HER2+ breast cancer that has spread to lymph nodes using MRI and MRX.
Who is it for?
You may be eligible for this study if you are a female aged 18 or older, you have histologically confirmed HER2+ primary breast cancer which you haven't had any prior treatment for (including surgery, radiotherapy, or systemic treatment) and you are scheduled for surgical intervention with lymph node detection by a specific diagnostic agent injection procedure being part of the surgical plan, or scheduled for a core biopsy of a lymph node that is clinically suspicious.
All enrolled participants will receive a subareolar (the pigmented area around the nipple) injection of the investigational agent after a baseline magnetic resonance imaging (MRI) scan on Day 1. The scan will last approximately 45 minutes.
Participants will return for another MRI in 24 hours (Day 2) and on Day 4 to detect the lymph node spread. Also on Day 4, participants will have a tissue sample (biopsy) taken from a cancerous lymph nodes for further examination. The biopsy will be investigated for standard of care as well as a new imaging technique called magnetic relaxometry (MRX).
As this study is investigating the safety of the investigational agent, participants will be asked to attend a series of seven clinic visits where they will provide up to three blood and urine samples.
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