Validation study on the clinical usefulness of the ICG fluoresence method for detecting sentinel lymph node in early breast cancer in comparion with the RI method

Validation study on the clinical usefulness of the ICG fluoresence method for detecting sentinel lymph node in early breast cancer in comparion with the RI method - Direct comparison between ICG fluoresence and RI method for SLN biospy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005167

Enrollment

840

Registered

2011-03-15

Start date

2011-04-01

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

early breast cancer

Interventions

Sentinel lymph node will be detected by ICG fluoresence method and RI mehod

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Early breast cancer patients without axillary involvement. 2)Patient who is to undergo SLN biopsy. 3) Written consent to join in this study has been obtained from the patient itself.

Exclusion criteria

Exclusion criteria: 1)Patients who had surgical biopsy or operation on the axilla. 2)Patient who had history of alleragy against ICG reagent or iodine. 3)Pregnant or breast feeding. 4)Patients who are judged inappropriate for the clinical trial by doctors.

Design outcomes

Primary

Measure	Time frame
sensitivity	—

Secondary

Measure	Time frame
1) identification rate of SLN 2)additive effect of ICG fluoresence method on RI method. 3) identificaiton rate of SLN before and after primary systemic therapy. 4) involvement in SLN and non SLN. 5) adverse event of ICG fluoresence method.	—

Countries

Japan,Asia(except Japan)

Contacts

Public ContactTomoharu Sugie

Graduate School of Medicine Kyoto University Breast Surgery

sugie@kuhp.kyoto-u.ac.jp075-751-3660

Outcome results

None listed

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