The evaluation of targeted axillary dissection with Hydromark and Guiding Marker System.
- Conditions
- Breast cancer
- Registration Number
- JPRN-jRCTs042210020
- Lead Sponsor
- Kotani Haruru
- Brief Summary
o adverse events were observed with the HydroMARK and Guiding-marker system, and the success rate of TAD was met in more than 90% of cases. Hence, we were able to demonstrate the usefulness of TAD with Guiding-marker system.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
1. Patients pathologically diagnosed with breast cancer and axillary lymph node metastasis.
2. Clinically confirmed 1 to 3 axillary lymph node metastases
3. Histological type can be anything.
4. Patients planning to receive standard neoadjuvant chemotherapy for primary breast cancer
5. Age at the time of consent is 20 years or older
6. ECOG Performance Status (PS) of 0 to 2
7. Meet all of the following criteria for organ function (within 21 days before registration)
(1) Neutrophil count >=1,500/mm3 or WBC >= 3,000/mm3
(2)Hemoglobin >= 8.0g/dL
(3) Platelet count >= 100,000/mm3
(4)Total bilirubin is 1.5 times or less of the normal upper limit
(5)AST (GOT) and ALT (GPT) <=100U/L
(6)Serum creatinine is less than 1.5 times the upper limit of normal.
8. The diseased upper limb can be lifted in the supine position.
9. Patients who submits written consent herself after receiving sufficient explanation about this study
1. Pregnant women, those with a positive pregnancy test, within 28 days after giving birth, or during lactation
2. Severe mental disease.
3. Patient who is assessed not applicable by investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Success rate of TAD using the guiding marker system with Hydromark<br>TAD is successful if all of the following are met<br>(1) Hydromark can be placed in metastasis-positive axillary lymph nodes<br>(2) Hydromark can be identified and Guiding Marker System can be inserted there, with US.<br>(3) Hydromark can be removed with using Guiding Marker System.<br>(4) Sentinel lymph node can be identified<br>2.Incidence of adverse events associated with hydromark placement<br>3.Incidence of adverse events by the guiding marker system
- Secondary Outcome Measures
Name Time Method 1.Evaluate the following in TAD cases<br>(1) Presence or absence of metastasis to Targeted LNs and Non-Targeted LNs(Ax case only) (false negative of TAD)<br>(2) Match rate between Clipped LN and SLN<br>(3) Number of Targeted LNs resection<br>(4)Identification rate of SLNB<br>2. Evaluate the following in ycN + cases<br>(1)Presence or absence of metastasis to Clipped LN<br>(2)Number of metastases to other than Clipped