Safety and Efficacy of MagSense HER2 Test Reagent - Clinical trial • Breast Cancer Foundation NZ

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Safety and Efficacy of MagSense HER2 Test Reagent

Early Breast Cancer clinical trials for HER2+

Updated: June 22, 2021

This study will assess the safety and effectiveness of an investigational agent (MSH2TR) used to detect lymph node spread of cancer in patients with HER2+ breast cancer.

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.

Study details

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.

Full trial information


Monash Medical Centre (Moorabbin campus), Melbourne
Austin Hospital, Melbourne


Geoff Hollis

If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

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