Ann: Appendix 4C - quarterly, page-56

info on the actual trial and how it is described.

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

MagSense (Trademark) Human Epidermal Growth Factor Receptor 2 (HER2) Test Reagent (MSH2TR) will be administered once only as a subareolar injection (the pigmented area around the nipple) near or around the tumour; at dose of 30mg as either a single 3mL injection or divided into 3 x 1mL injections next to each other if the volume of injection causes discomfort, after the baseline MRI and approximately 72 hours prior to the scheduled biopsy. If 30mg is not tolerated by more than 2 subjects in the first cohort of 6 subjects, MSH2TR will be administered at 20mg either a single injection or divided into 2 x 1ml injections next to each other if the volume of injection causes discomfort.

Titles & IDs

Public title

Safety and Efficacy of MagSense Human Epidermal Growth Factor Receptor 2 (HER2) Test Reagent in Breast Cancer Lymph Node Magnetic Reasonance Imaging (MRI) and Magnetic Relaxometry (MRX).

Scientific title

A Phase I Study Investigating the Safety and Efficacy of the MagSense (Trademark) Human Epidermal Growth Factor Receptor 2 (HER2) Test Reagent Using Magnetic Resonance Imaging and the MagSense (Trademark) Instrument in Subjects with HER2-positive Breast Cancer to Test for Ipsilateral Lymph Node Involvement

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380834&showHistory=true&isReview=true