The evaluation of targeted axillary dissection with Hydromark and Guiding Marker System.

Study on the safety and usefulness of targeted axillary dissection using the Hydromark and Guiding Marker System after Neo-Adjuvant chemotherapy for breast cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042210020

Enrollment

Registered

2021-05-17

Start date

2021-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Hydromark are placed in patients diagnosed with 1 to 3 axillary lymph node metastases prior to neoadjuvant chemotherapy (NAC). Targeted Axillary Dissection (TAD) is performed using the Guiding Marker

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.Success rate of TAD using the guiding marker system with Hydromark TAD is successful if all of the following are met (1) Hydromark can be placed in metastasis-positive axillary lymph nodes (2) Hydromark can be identified and Guiding Marker System can be inserted there, with US. (3) Hydromark can be removed with using Guiding Marker System. (4) Sentinel lymph node can be identified 2.Incidence of adverse events associated with hydromark placement 3.Incidence of adverse events by the guiding marker system	—

Measure

Time frame

1.Success rate of TAD using the guiding marker system with Hydromark TAD is successful if all of the following are met (1) Hydromark can be placed in metastasis-positive axillary lymph nodes (2) Hydromark can be identified and Guiding Marker System can be inserted there, with US. (3) Hydromark can be removed with using Guiding Marker System. (4) Sentinel lymph node can be identified 2.Incidence of adverse events associated with hydromark placement 3.Incidence of adverse events by the guiding marker system

—

Secondary

Measure	Time frame
1.Evaluate the following in TAD cases (1) Presence or absence of metastasis to Targeted LNs and Non-Targeted LNs(Ax case only) (false negative of TAD) (2) Match rate between Clipped LN and SLN (3) Number of Targeted LNs resection (4)Identification rate of SLNB 2. Evaluate the following in ycN + cases (1)Presence or absence of metastasis to Clipped LN (2)Number of metastases to other than Clipped LN	—

Measure

Time frame

1.Evaluate the following in TAD cases (1) Presence or absence of metastasis to Targeted LNs and Non-Targeted LNs(Ax case only) (false negative of TAD) (2) Match rate between Clipped LN and SLN (3) Number of Targeted LNs resection (4)Identification rate of SLNB 2. Evaluate the following in ycN + cases (1)Presence or absence of metastasis to Clipped LN (2)Number of metastases to other than Clipped LN

—

Contacts

Public ContactYuka Endo

Aichi Cancer Center Hospital

y.endo@aichi-cc.jp+81-52-762-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026