Status:
COMPLETED
Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy
Lead Sponsor:
Olive Healthcare
Conditions:
Breast Cancer
Breast Tumor
Eligibility:
FEMALE
19+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Female aged 19 years or older
- ACR BI-RADS Category 3-5 (5th edition, 2023 update)
Exclusion
- 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
Key Trial Info
Start Date :
April 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06597175
Start Date
April 16 2024
End Date
December 16 2024
Last Update
August 13 2025
Active Locations (5)
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1
Seoul National University Bundang Hospital
Seongnam-si, South Korea
2
Kangbuk Samsung Hospital
Seoul, South Korea
3
Korea University Anam Hospital
Seoul, South Korea
4
Severance Hospital
Seoul, South Korea