Development of a new super-resolution ultrasound test to find cancerous sentinel lymph nodes in patients with breast cancer

Phase 1

• Conditions: Identification of malignant axillary lymph nodes in patients with breast cancer; Cancer

• Registration Number: ISRCTN49514912
• Lead Sponsor: Maidstone and Tunbridge Wells NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-03
• Last Update Posted: 15 November 2021
• Study Completion: 2023-04-04

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The functional ability of the prototype super-resolution CEUS system measured using tissue phantoms during the first 6 months of the study<br> 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<br> 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.<br> 4. The inter-rater reliability of imaging specialists measured with an observer study conducted between months 28 and 36 of the study<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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)<br> 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<br> 3. Patient and clinical satisfaction measured with patient and imaging specialist questionnaires completed immediately after each super-resolution CEUS test<br> 4. Stakeholder analysis and pathway mapping conducted using a WHO stakeholder analysis framework and completed by month 30<br> 5. Health economics report produced from information from the stakeholder analysis and clinical studies by month 30<br>