Early breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Using a stopwatch, research staff have the ability to consent and then actively monitor (shadow around the hospital) a group of ~20 patients in each treatment group (Magtrace® vs routine care using Te
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Female aged 18 years or above 3. Diagnosed with breast cancer (invasive) requiring Magseed® localisation and sentinel node biopsy 4. Willing to allow her General Practitioner and consultant, if appropriate, to be notified of participation in the study 5. Undergoing breast-conserving surgery with sentinel node biopsy 6. Surgeons may only operate on the Magtrace arm of the study if they have completed a minimum of five training cases with Magtrace
Exclusion criteria
Exclusion criteria: 1. Patients with a pacemaker or implanted device in the chest wall 2. Patients who are pregnant or lactating 3. Patients who have received Magtrace® (iron oxide) injection in the previous 6 months 4. Patients with previous ipsilateral axillary surgery 5. Patients whose breast and axillary surgery are not due to be performed synchronously 6. Patients following neoadjuvant chemotherapy 7. Patients who require MRI follow-up of the ipsilateral breast in the year following surgery (as Magtrace® may interfere with MRI) 8. Patients requiring an interpreter 9. Patients involved in current research or have recently been involved in any research prior to recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cost-effectiveness of Magtrace® compared to Technetium in the identification of sentinel nodes in breast cancer, measured using data records over duration of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient time spent in hospital and in transit in total over the preoperative and perioperative journey, measured using electronic patient records over the duration of the patient visit. 2. Patient anxiety on the day of surgery measured using the State-Trait Anxiety Inventory (STAI-Y) given on the ward on the morning of surgery 3. Number and length of patient hospital visits comparing preoperative visits (clinic visits, preoperative assessment, tracer injection visits, ward visits and operative visits), measured on the day of surgery 4. Safety of Magtrace® and efficacy: adverse events relatable to tracers, number of nodes removed, number of nodes containing tracer, % of patients with detectable tracer in the axillary sentinel nodes, can surgeons differentiate Magtrace® and Magseed signal®, recorded for as long as the participant is on the trial 5. Cost per episode and for total care, measured using activity-based costing (TDABC). TDABC is a bottom-up approach to healthcare pathway mapping and costing, which records pathways observed during routine clinical practice, identifies all points and durations of interaction with healthcare providers therein; and assigns time-dependent costs to each constituent. 6. Surgical start time, days of week of operating, and delays to getting patients to the theatre. Delays will be recorded by asking the theatre team directly pre-operatively whether they had to wait for the patient to arrive and what the reason was, and also whether the list had to be rescheduled/moved to accommodate a delay, measured using electronic patient records over the duration of the patient visit. 7. Current pathways of patient care: the research assistants provide a ‘learned’ assessment of what they believe represents a ‘typical’ pathway at the Nightingale centre. A multidisciplinary team will then assess the validity of this pathway and voice any concerns/objections/potential additions. The duration of each patient visit is monitored throughout the tria | — |
Countries
England, United Kingdom
Outcome results
None listed