Microbubble detection and ultrasound guided biopsy of armpit glands in patients with breast cancer
- Conditions
- Diagnosis of lymph node metastases in patients with newly diagnosed breast cancer.MedDRA version: 14.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: LLT Classification code 10006203 Term: Breast cancer stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-001889-14-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 139
To be included in the study the patients must:
- aged 18 years or over
- have biopsy proven invasive breast cancer
- have SLN biopsy recommended as part of their standard surgical management for breast cancer
- be able to give written informed consent
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 106
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
The presence of any of the following will preclude patient inclusion:
- unable to provide written informed consent
- aged 17 years or under
- history of previous ipsilateral breast cancer
- prior ipsilateral axillary surgery
- pregnant or lactating women
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