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

Phase 3

Active, not recruiting

• Conditions: Breast Cancer; Breast Tumor; Mammary Carcinoma, Human
• Interventions: Device: ORIGO

• Registration Number: NCT06597175
• Lead Sponsor: Olive Healthcare

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-16
• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-19
• Primary Completion: 2024-11-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device: ORIGO	ORIGO	-

Primary Outcome Measures

Name	Time	Method
Concordance	Through study completion, an average of 6 months	Concordance between biopsy results (Gold standard) and the device test results for breast lesions in subjects

Trial Locations

Locations (5)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Yongin Severance Hospital; 🇰🇷 Yongin-si, Korea, Republic of