None listed
Conditions
Brief summary
This study will assess the safety and effectiveness of an investigational agent (MSH2TR) used to detect lymph node spread of cancer in patients with a specific type of breast cancer, HER2-positive breast cancer. 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-positive 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 (7) clinic visits where they will provide up to three (3) blood and urine samples. 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 HER-2 positive breast cancer that has spread to lymph nodes using MRI and MRX.
Interventions
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
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.
Sponsors
Imagion Biosystems, Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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,
Exclusion criteria
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.
Outcome results
None listed