Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy

Olive Healthcare300 enrolled

Overview

This is a multicenter, pivotal clinical trial to evaluate the safety and efficacy of a diagnostic device used to assist in the differentiation of breast tumors in patients with breast lesions detected by ultrasound alone or by both ultrasound and mammography.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

300

Conditions

Breast Cancer Breast Tumor Mammary Carcinoma, Human

Interventions

ORIGODEVICE

The device measurement is first performed on the breast area with the lesion, followed by the measurement of the corresponding area in the contralateral breast for comparison.

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female aged 19 years or older * ACR BI-RADS Category 3-5 (5th edition, 2023 update) Exclusion Criteria: * Pregnant, potentially pregnant, or currently breastfeeding * Calcifications detected on mammography but do not have corresponding lesions identified on ultrasound * Biopsy performed on the same breast within 7 days prior to the date of informed consent * Significant trauma or scarring at the measurement site, or those suffering from mastitis. * Breast implants, electronic medical devices such as pacemakers, or with a space left in the breast cavity due to implant removal * History of phototoxic reactions or light sensitivity

Locations (5)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Concordance

Concordance between biopsy results (Gold standard) and the device test results for breast lesions in subjects

Time frame: Through study completion, an average of 6 months

Data from ClinicalTrials.gov

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