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ACTIVE NOT RECRUITING
NCT06412211

A Clinical Feasibility Study of a Photoacoustic Finder

Sponsor: Seoul St. Mary's Hospital

View on ClinicalTrials.gov

Summary

Determining the prognosis of breast cancer relies significantly on axillary staging by sentinel lymph node biopsy (SLNb). The SLNb is generally performed using radioisotopes, blue dyes, or both to improve the false negative rate. However, a gamma probe with radioisotopes involves ionizing radiation, and blue dye detection relies on visual inspection by an operator. To overcome these limitations, the photoacoustic finder (PAF) was developed as a highly sensitive, non-radioactive detector that uses only blue dye and a photoacoustic signal to detect SLNs. To evaluate the PAF, its performance was compared with the standard SLN detection method for breast cancer patients.

Official title: Clinical Utility of Photoacoustic Finder in Sentinel Lymph Node Detection in Breast Cancer - Pilot Study

Key Details

Gender

All

Age Range

19 Years - 74 Years

Study Type

OBSERVATIONAL

Enrollment

129

Start Date

2021-12-07

Completion Date

2024-09-30

Last Updated

2024-05-14

Healthy Volunteers

No

Interventions

DEVICE

Photoacoustic finder

Sentinel lymph node detector using photoacoustic signal

Locations (1)

Seoul St. Mary's hospital

Seoul, South Korea