None listed
Conditions
Brief summary
This study will investigate the feasibility and validity of Magnetic Sentinel Lymph Node Mapping with FerroTrace in Breast Cancer Who is it for? You may be eligible to join this study if you are female, aged between 18 and 75 years, have a confirmed diagnosis of primary breast cancer and are scheduled for a lumpectomy and a sentinel lymph node biopsy (SLNB) procedure as part of the surgical plan. Study details All participants in this study will receive single dose of FerroTrace and a single dose of radioisotope via intraparenchymal injections into the breast tissue the day prior to, or on the morning of, surgery. During surgery, a modified sentinel lymph node biopsy (SLNB) will be performed, using a magnetometer probe to locate the magnetic tracer in sentinel nodes, followed by the standard gamma probe. At least one follow-up MRI of the breast will be performed 30 days after surgery, to assess tracer clearance, with additional MRIs at 90 days and 180 days after surgery if there is not complete clearance on the earlier post-operative MRI. It is hoped that this research project will lead to further studies and eventually the technology will be widely available so that patients with can have breast cancer surgery without the use of radioactive isotopes and dye.
Interventions
This is a single centre, open label, side-by-side comparator study to assess the feasibility and validity of using FerroTrace for mapping sentinel lymph nodes (SLNs) in subjects diagnosed with breast cancer, and to investigate clearance of the tracer from the injection site. A maximum of 20 subjects will be enrolled. Eligible subjects will receive both a single 0.4-0.5ml surgeon injected dose of FerroTrace and a single radiologist injected dose of Technetium (99mTc) antimony sulphide colloid via
This is a single centre, open label, side-by-side comparator study to assess the feasibility and validity of using FerroTrace for mapping sentinel lymph nodes (SLNs) in subjects diagnosed with breast cancer, and to investigate clearance of the tracer from the injection site. A maximum of 20 subjects will be enrolled. Eligible subjects will receive both a single 0.4-0.5ml surgeon injected dose of FerroTrace and a single radiologist injected dose of Technetium (99mTc) antimony sulphide colloid via intraparenchymal injections into the breast tissue the day prior to, or on the morning of, surgery. During surgery, a modified sentinel lymph node biopsy (SLNB) will be performed, using a magnetometer probe to locate the magnetic tracer in sentinel nodes, followed by the standard gamma probe to locate the Technetium (99mTc) antimony sulphide colloid. To assess tracer clearance, at least one follow-up MRI of the breast will be performed 30 days after surgery, with additional MRIs at 90 days and 180 days after surgery if there is not complete clearance on the earlier post-operative MRI.
Sponsors
Ferronova Pty 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 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is capable of understanding, and willing to provide, written informed consent. 2. Female between 18 and 75 years of age (inclusive) at the time of providing informed consent. 3. Subject with a confirmed diagnosis of primary breast cancer. 4. Subject is scheduled for lumpectomy and an SLNB procedure as part of the surgical plan. 5. Subject has a clinical negative node status (i.e., cN0) at the time of providing informed consent. 6. Pre-menopausal subjects must be willing to use methods of contraception as deemed adequate by the Investigator to be eligible for, and continue participation in, the study. 7. Subject has had contrast-enhanced mammography showing no, minimal, or mild background parenchymal enhancement. 8. In the opinion of the Investigator, the subject can complete the study in compliance with the protocol and is able to comply with the requirements of the study protocol. 9. Subjects with an ECOG performance status of Grade 0–2.
Exclusion criteria
1. Subject has had preoperative radiation therapy to the affected breast or axilla. 2. Subject has received a Feraheme® (ferumoxytol) injection within the past 180 days. 3. Subject has a known history of allergies, hypersensitivity, or intolerances as follows: a. Iron compounds b. Polyacrylamide c. PEG d. Known or suspected hypersensitivity to the investigational product, or to any ingredients of the investigational product. 4. Subject known to have haemochromatosis 5. Subject has a co-morbid condition with an estimated life expectancy of <180 days at the time of consent. 6. Subjects who are pregnant, trying to fall pregnant in prior 14 days, or lactating at time of screening. 7. Subject has participated in another investigational drug study within 30 days of scheduled surgery. 8. Subject has one or more absolute contraindications to MRI scanning as per Investigator judgement. 9. Subject has had contrast-enhanced mammography showing moderate or marked background parenchymal enhancement. 10. Subject has a genetic mutation or family history of breast/ovarian cancer such that MRI is recommended as a screening modality. 11. Subjects with an eGFR of < 30 ml/min/1.73m2. 12. Subject has a metallic implant of any type in the chest wall, including pacemakers and implantable defibrillators. 13. Subject has inability or unwillingness to comply with all follow-up through to the end of the study, and/or unwilling to allow review of medical records in accordance with local regulatory requirements at time of consent. 14. Investigator determines that the subject is not suitable for study participation for any other reason (e.g., Subject has had previous axilla surgery, or lymphatic function that is impaired in the surgeon’s judgment).
Outcome results
None listed