Technical assessment and diagnostic accuracy of contrast enhanced ultrasound to identify sentinel lymph node metastases in breast cancer patients following training and mentorship of imaging specialists
- Conditions
- Breast Cancer - Using SonoVue injected intradermally into the breast and contrast enhanced ultrasound to see if the cancer has spread via lymphatic channels to sentinel lymph nodes in the axilla.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2020-000819-67-GB
- Lead Sponsor
- Maidstone and Tunbridge Wells NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 250
Histologically confirmed invasive carcinoma of the breast without palpable axillary lymph nodes with planned
primary surgical treatment.
Normal B-mode axillary ultrasound or benign biopsy of morphologically abnormal lymph nodes.
Participant is willing and able to give informed consent for participation in the trial.
Aged 18 years or above.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
Previous ipsilateral breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
Female participant who is pregnant, lactating or planning fertility preservation during the course of the
trial.
Allergy to contrast.
Inflammatory or locally advanced breast cancer.
Metastatic breast cancer.
Inability to raise ipsilateral arm above head.
Multiple medical co-morbidities (ASA 4 or above).
Previous ipsilateral axillary surgery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method