Breast Cancer MedDRA version: 20.0 Level: LLT Classification code 10072873 Term: Sentinel lymph node mapping System Organ Class: 100000004848
Conditions
Sponsors
DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient diagnosed with ductal breast cancer infiltrated T 0-2 N0 M0 to which was proposed after discussion at the multidisciplinary meeting an upfront surgery and sentinel lymph node biopsy. - age >18 - Weight 40-85 kg - Infiltrating neoplasia - No evidence of clinically suspicious axillary lymph nodes Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Patients with remote metastases - Patients undergoing Neonatal chemotherapy or previously undergoing chest radiotherapy - Patients undergoing homolateral breast QSE surgery - Patients undergoing surgery in the homolateral armpit region - Patients who have not expressed, or are unable to do so, informed consent to the study - Counter-indications of postoperative radiotherapy - Personal history of allergy to lidocaine, ultrasound contrast, scintigraphic or vital dyes such as methylene blue - Patient with infection or cellulite of the breast region, upper limb and chest treatment site - Ongoing pregnancy - Patients who have previously expressed a desire to be followed in the post-treatment multidisciplinary follow-up by another facility - Patients with any other contraindication to CEUS or lymphatic scintigraphy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the validity of CEUS ultrasound with subcutaneous means of contrast SonoVue, compared to other methods and examinations already consolidated in clinical practice.;Secondary Objective: - Opinions and pain of patients at the end of the CEUS procedure, of all possible complications highlighted in the literature and not present in the literature after the CEUS procedure and after surgery. - Procedure times of percutaneous procedure, all-out surgery, sentinel lymph node biopsy and CEUS procedure. - Costs of sentinel lymph node procedure and CEUS guided percutaneous procedure.;Primary end point(s): The primary end point of this study is to assess the number of lymph nodes highlighted by the standard lymphoscintigraphic tracer procedure combined with the use of the ultrasound tracer and the rate of agreement on the number of sentinel lymph nodes identified with the traditional procedure with respect to the procedure by means of ultrasound contrast.;Timepoint(s) of evaluation of this end point: At the end of the ultrasound | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Questionnaires - Measure of time - Average costs will be calculated on the average of the above times;Timepoint(s) of evaluation of this end point: At the end of the ultrasound and surgery | — |
Countries
Italy
Contacts
Public ContactClinical Operations
Link Neuroscience and Health Care srl - L.N.Age srl
Outcome results
None listed