Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

The included patients will accept essential tests and CEUS before and after neoadjuvant chemotherapy to evaluate axillary lymph nodes status. When patients finish neoadjuvant therapy, SLNB with or without axillary lymph node dissection will be performed using CEUS lymphatic mapping to mark SLN on the skin combined with blue dye.

CEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node.

CEUS

Before operation, blue dye is injected for sentinel lymph node mapping.

blue dye

Ying Lin

Zhen Shan

False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. But radioisotope is still not approved in China and can cause radiocontamination. A novel dual-tracer which can decrease the FNR in patients after neoadjuvant therapy is urged to be explored. Contrast enhanced ultrasonography (CEUS) can make the lymphatic drainage path and sentinel lymph nodes visible. Retrospective studies found that CEUS can locate SLN precisely. So this clinical trial aim to evaluate FNR, detective rate and numbers of SLN by using CEUS combined with blue dye as dual-tracer in sentinel lymph node biopsy in breast cancer patients after neoadjuvant therapy and the accuracy of CEUS for the diagnosis of lymph node metastasis before and after neoadjuvant therapy.

Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy

A Prospective Multi-center Study: Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy After Neoadjuvant Therapy in Breast Cancer

The false negative rate (FNR) of sentinel lymph node biopsy using dual-tracer with CEUS and blue dye after neoadjuvant chemotherapy in invasive breast cancer patients.

The FNR is calculated as the number of false negative cases divided by the number of false negative plus true positive cases and then multiplied by 100%.

The detective rate of SLNB after neoadjuvant therapy when using blue dye and CEUS lymphatic mapping as dual tracer.

The detective rate is calculated as the number of patients in whom SLN can be detected during SLNB divided by the number of patients with the treatment of SLNB and then multiplied by 100%.

The average numbers of sentinel lymph node is calculated as the number of all SLNs detected during SLNB divided by the number of patients received SLNB and then multiplied by 100%.

The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer patients before and after neoadjuvant therapy.

The accuracy rate is calculated as the number of true positive plus true negative cases divided by the number of patients then multiplied by 100%.

The Seventh Affiliated Hospital of Sun Yat-sen University

Affiliated Hospital of Guangdong Medical University

First Affiliated Hospital of Shantou University Medical College

First Affiliated Hospital, Sun Yat-Sen University

Vice Director of Department of Breast Surgery

Myoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Three contrast-enhanced ultrasonography : before embolization, after one day and after 6 months.

Abdominal route 2.4 ml sonovue per injection / bolus

contrast enhanced ultrasonography

Intervention is described in the case report form for each patient

embolization

Henri MARRET, Pr

Catherine ROUSSEL, ARC

François TRANQUART, Pr

Aurore BLEUZEN, MD

Denis HERBRETEAU, Pr

Marc LEGEAIS, MD

Nathalie WAGNER, MD

Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as improve the follow-up after specific treatments like embolization. It will also help the investigators better understand the mechanism of success or failure for embolization and could reduce the amount of particles injected by determining the endpoint of the procedure in order to treat the myomas while preserving the myometrium.

Before embolization of the uterine artery, 40 patients with unique or multiple myomas will be included prospectively in our study and evaluated with sonography before and after injection of Sonovue (2.4 ml) (Bracco Int Milano Italy). Pelvic ultrasound with contrast enhancement will be done the day after and six months after the procedure.

Microvascularization of the myomas and the endometrium will be described. Some tiny myomas which are not visible on conventional sonography could be identified for a perfect matching with MRI detection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy	NCT04932460	Breast Neoplasm... Neoadjuvant The... Sentinel Lymph ...	CEUS blue dye	18 Years -	First Affiliated Hospital, Sun Yat-Sen University
Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization	NCT00351494	Myoma	contrast enhanc... embolization	18 Years -	University Hospital, Tours

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