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+

Recruiting
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

Australia

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

Contact:

Geoff Hollis

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

Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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Are we out of date? If you have updated or new information about a trial, we’d be grateful if you’d share it with us – email your update to intouch@bcf.org.nz

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