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Completed

NCT Number: NCT06597175

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Tumor Mammary Carcinoma, Human Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital, Seongnam-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORIGO

Device

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.

Primary outcomes

  1. Concordance

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

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

Sponsors and collaborators

Lead sponsor

Olive Healthcare

Industry

Registry information

Official study title

A Multi-center, Open-label, Single Arm, Prospective Pivotal Medical Device Clinical Trial to Evaluate Efficacy and Safety of Study Device (ORIGO) That Provides Numerical Data by Measuring the Composition Within Breast Tissue Using Diffusion Optical Spectroscopy Imaging Technology to Assist in the Differential Diagnosis of Breast Tumors in Patients With Breast Lesions

Acronym: ORIGO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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