A Prospective Open Label Study of Patient Reported Outcome Measures and Efficacy Following the Use of 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients Undergoing Lumpectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Endomagnetics Ltd.
- Enrollment
- 184
- Locations
- 2
- Primary Endpoint
- Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures.
Detailed Description
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node (SLN) detection rate in patients who have received 1ml Magtrace for Sentinel Lymph Node Biopsy (SLNB) and to evaluate the impact that skin discoloration has on patients when it does occur using patient reported outcome measures utilising BREAST-Q. Baseline assessment using BREAST-Q will performed. A key secondary objective is to demonstrate non-inferiority of sentinel lymph node (SLN) detection rate with Magtrace compared to the American Society of Breast Surgeons (ASBRS) performance standards. All participants will undergo lymph node mapping with Magtrace, and Sentinel Lymph Node Biopsy undertaken and nodes localised with the Sentimag system, A sentimag count will be recorded for each node removed. After completion of the surgery, at the postoperative visit the presence of Magtrace related discoloration will be assessed by the Investigator. Participants found to have no Magtrace related discoloration will be asked to complete the Post-Op BREAST-Q assessment and return at 12 months post-op for a follow-up visit. Those patients assessed as having the presence of Magtrace related skin discoloration will be asked complete the post-op BREAST-Q and will then undergo assessment of the size and severity of the discoloration. They will then be asked to return at 6, 12, 18 and 24 months for follow-up visits, or until the discoloration has resolved. At each of these visits the BREAST-Q will be completed, and the size and severity assessment will be performed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is willing and able to give informed consent for participation in the study
- •Patient is aged 18 years or older at the time of consent
- •Patients undergoing planned breast conserving surgery (for example, lumpectomy or partial mastectomy) and SLNB with Magtrace
Exclusion Criteria
- •The patient is pregnant or lactating
- •The patient has had prior breast radiation to the ipsilateral breast
- •The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
- •The patient has recevied a Feraheme (ferumoxytol) injection within the past 6 months
- •The patient has intolerance or hypersensitivity to iron or dextran compounds or to Magtrace
- •The patient has iron overload disease
- •The patient has discoloration on the breast (such as tattoo, birthmark, tanning, rash etc.), that in the Investigator's opinion, could impact the clinical trial results, specifically the assessment of any skin discoloration, or plans to have a tattoo on the breast post-operatively.
Outcomes
Primary Outcomes
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample
Time Frame: post-op to 24 month follow-up
Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample
Secondary Outcomes
- Change in BREAST-Q score from post-operative visit through to resolution of skin discoloration or through 24 months, whichever is earlier, in the subgroup of patients with discoloration. 7 core scales will be used.(Baseline to 24 month follow-up)
- Change in BREAST-Q score from pre-operative visit to post-operative visit in patients with and without skin discoloration at the post-op follow-up visit.(Pre-op to Post-Op)
- Duration of discoloration over time post-op to resolution of discoloration or 24 month follow-up(Post-op to 24 month follow-up)
- Intensity of discoloration (absolute color and contrast to normal breast color) over time post-op to resolution of discoloration or 24 month follow-up(Post-Op to 24 month follow-up)
- Severity of discoloration over time post-op to resolution of discoloration or 24 month follow-up as assessed by height and width measurement(Post-Op to 24 month follow-up)
- Rates of device-related adverse events and serious device-related adverse events(Baseline to 24 month follow-up)
- Number of identified SLNs per patient(Surgery)
- Number of non-Magtrace marked nodes per patient removed (clinically suspicious)(Surgery)
- Nodal malignancy rate(Surgery)