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).
- Conditions
- Breast CancerCancer - Breast
- Registration Number
- ACTRN12621000126819
- Lead Sponsor
- Imagion Biosystems, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 30
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;
* Previous radiation to the ipsilateral breast or axilla;
* Known metal implant in the ipsilateral axilla or in the ipsilateral chest;
* Any contraindications to MRI imaging;
* Any implant anywhere in the body that produces a magnetic field;
* Recent history of ferumoxytol therapy in the past 6 months;
* Subject received an investigational agent (treatment or diagnostic) within 30 days prior to the surgery;
* Clinically significant acute illness within 4 weeks or other illness deemed to be significant by investigator with agreement of sponsor within 5 days before Day 1;
* Subject, in the opinion of the investigator, should not participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events via clinical examination and classifed by CTCAE v5.0 criteria[Days 1, 2, 3, 4, 7 and 28];Incidence of serious adverse events via clinical examination & review of medical records and classified by CTCAE v5.0 criteria[Days 1, 2, 3, 4, 7 and 28 ];Clinically significant changes from baseline measured by haematology (blood sample) and chemistry parameters (blood and urine samples).[Screening and on days 1, 2 and 4.]
- Secondary Outcome Measures
Name Time Method ymph node detection rate of the test reagent assessed by iron and HER2 histological staining of the lymph node biopsy samples (colocalisation).[Day 4 ];Lymph node detection rate assessed by MRI scan of the upper body (lymph nodes).[On Days 2 and 4.];Lymph node detection rate assessed by MRX imaging of the lymph node biopsy samples.[Day 4];Lymph node detection rate identified by MRX imaging of the lymph nodes compared with MRI imaging and the histological findings of the lymph nodes (Iron staining and HER2 status).[Day 4];Incidence of injection site reactions by clinical examination and classified by CTCAE v5.0 criteria (additional primary outcome).[At Days 1, 2, 3, 4, 7 and 28 days post test reagent administration ]