Trials / Unknown
UnknownNCT04932460
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | CEUS | CEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node. |
| PROCEDURE | blue dye | Before operation, blue dye is injected for sentinel lymph node mapping. |
Timeline
- Start date
- 2021-06-15
- Primary completion
- 2023-07-15
- Completion
- 2023-08-15
- First posted
- 2021-06-21
- Last updated
- 2021-06-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04932460. Inclusion in this directory is not an endorsement.