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 sta
Conditions
Interventions
Trade Name: Sonovue
Product Name: Sulphur Hexafluoride (Sonovue)
Pharmaceutical Form: Powder and solvent for dispersion for injection
INN or Proposed IN
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To see if using an ultrasound visible "dye" (microbubble) to detect the sentinel lymph node draining the breast and to comprehensively biopsy the node once identified can significantly improve the pre-operative diagnosis of axillary (armpit) lymph gland (node) cancer deposits in patients with breast cancer.; Secondary Objective: To determine the percentage of patients whose nodes could be identified with ultrasound visible "dye" (microbubble). To determine the percentage of patients whose nodes could be identified with ultrasound visible "dye" (microbubble) who then underwent successful comprehensive biopsy using a vacuum assisted biopsy device. ;Primary end point(s): The primary outcome measure is the incidence of lymph node metastases diagnosed on pre-operative biopsy using the microbubble guided biopsy technique.;Timepoint(s) of evaluation of this end point: Analysis will take place at the end of the study. Patients will undergo an intradermal injection of Sulphur Hexafluoride and the contrast will be traced to the axilla and the first draining SLN will be identified. The identified SLN will then be comprehensively biopsied with the aim of removing the identified node. Any patient without metastatic deposits will proceed to SLNB as before. Any patient whose lymph node reveals metastases will not require an SLNB and may proceed directly to surgical excision of all their remaining axillary lymph nodes. The findings in patients undergoing successful percutaneous biopsy will be compared with final surgical histology whether SLNB or ALND. The improvement in the pre-operative diagnosis rate using this technique can then be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the percentage of patients whose nodes could be identified with Sulphur Hexafluoride. To determine the percentage of patients whose nodes could be identified with Sulphur Hexafluoride who underwent successful vacuum assisted biopsy. ;Timepoint(s) of evaluation of this end point: As with the primary endpoints analysis will take place at the end of the study. | — |
Countries
United Kingdom
Contacts
Public ContactCarrie Bayliss
Cambridge Clinical Trials Unit
Outcome results
None listed