Identification of malignant axillary lymph nodes in patients with breast cancer Cancer
Conditions
Interventions
Work Plan 1
Work on test phantoms:
While the current image data acquisition using the Verasonics research ultrasound machine is ultrafast (>10 kfps), the image formation and super-resolution process
2) an electromagnetic device connected to track the probe
3) the probe finally being scanned across the armpit while ultrafast data is acquired. An optimal balance between the numbers of 2D scan planes and the total time required will be sought. Imaging meth
Sponsors
Maidstone and Tunbridge Wells NHS Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Histologically confirmed invasive carcinoma of the breast with planned primary surgical treatment 3. Female aged 18 to 80 years 4. In the Investigator’s opinion, adhering to the trial recommendations and governance
Exclusion criteria
Exclusion criteria: 1. Previous ipsilateral breast cancer treated with radiotherapy or chemotherapy 2. Participant who is pregnant, lactating or planning pregnancy during the course of the study 3. Allergy to ultrasound contrast 4. Cannot provide consent 5. Inflammatory or locally advanced breast cancer 6. Patients with right to left cardiac shunts 7. Severe pulmonary hypertension 8. Adult respiratory distress syndrome 9. Uncontrolled hypertension 10. Heart failure 11. Renal failure 12. Recent thromboembolism 13. Hypercoagulation disorder
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events measured with patient questionnaires completed immediately after the super-resolution CEUS test and clinician questionnaires completed on the day of surgical treatment (approximately 2-3 weeks after the super-resolution CEUS test) 2. Feedback on perceived usability collected through validated scales (UMUX, System Usability Scale - SUS, NET promoter score) from imaging specialists after each super-resolution CEUS test 3. Patient and clinical satisfaction measured with patient and imaging specialist questionnaires completed immediately after each super-resolution CEUS test 4. Stakeholder analysis and pathway mapping conducted using a WHO stakeholder analysis framework and completed by month 30 5. Health economics report produced from information from the stakeholder analysis and clinical studies by month 30 | — |
Primary
| Measure | Time frame |
|---|---|
| 1. The functional ability of the prototype super-resolution CEUS system measured using tissue phantoms during the first 6 months of the study 2. Time to event measures of the prototype super-resolution CEUS system: visualisation of lymphatics, visualisation of SLN in axilla and core biopsy and clip SLN recorded for each clinical procedure 3. Diagnostic performance assessed by calculating the sensitivity, specificity, positive predictive value and negative predictive value of the prototype super-resolution system as a test to identify sentinel lymph node metastases compared to the reference standard of axillary surgery. The statistical report will be provided by month 32 of the study. 4. The inter-rater reliability of imaging specialists measured with an observer study conducted between months 28 and 36 of the study | — |
Countries
England, United Kingdom
Outcome results
None listed