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

Imagion Biosystems, Ltd0 sites30 target enrollmentFebruary 8, 2021

Overview

No summary available.

Registry

who.int

Start Date

February 8, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sex

Female

Sponsor

•To be eligible for study entry subjects must satisfy all of the following criteria
•\* Female subjects
•\* Written informed consent provided for participation in the study;
•\* In the opinion of investigator, willing and able to comply with required study procedures;
•\* Histologically confirmed HER2\-positive primary breast cancer;
•\* No prior treatment for breast cancer including surgery, radiotherapy, or systemic treatment;
•\* In the investigator’s judgment from previous clinical, pathological, or imaging evidence have a likelihood of having at least 1 lymph node metastasis;
•\* Scheduled for surgical intervention with a SLNB and/or ALND as guided by technetium\-99m (99mTc) diagnostic agent injection procedure being part of the surgical plan, or scheduled for a core biopsy of a node that is clinically suspicious, or have already had a lymph node biopsy and are willing to have a second core biopsy;
•\* A female subject who is not pregnant or breastfeeding,

•Subjects will be excluded from the study if 1 or more of the following criterion are applicable:
•\* Contraindications to the use of any aid in detecting nodes during surgery including other magnetic localisation systems or 99mTc\-based diagnostic agents for those subjects scheduled for a SLNB and/or ALND;
•\* Known hypersensitivity to iron oxide or polyethylene glycol compounds;
•\* For those subjects scheduled for a SLNB and/or ALND, contraindications to the use of 99mTc diagnostic agents;
•\*Prior history of iron overload disease;
•\* Known clinical or radiological evidence of distant metastases (Stage IV disease);
•\* Known inflammatory breast cancer;
•\* Prior surgical axillary procedure including SLNB or ALND on the ipsilateral side of the breast cancer primary;
•\* Prior history of breast cancer;
•\* History of lymphoma with breast or axillary node involvement;