CompletedPhase 3

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

South Korea300 participantsStarted 2024-04-16

Plain-language 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.

Who can participate

Age range19 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Concordance

Timeframe: Through study completion, an average of 6 months

Trial details

NCT IDNCT06597175

SponsorOlive Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-29

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