IRB Study Number 22-352
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Digestive Disease & Surgery Institute
Description
This study is investigating intraoperative specimen imaging using the Clarix Imaging Volumetric Specimen Imager (VSI) to intraoperatively direct cavity shaves followed by completion of standard of care in women with invasive breast cancer and/or ductal carcinoma in situ (DCIS) who are undergoing breast conservation surgery (lumpectomy or partial mastectomy).
Inclusion Criteria
Woman ≥ 18 years of age
Histologically confirmed invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component
Invasive breast cancer and/or DCIS lesion must have been visualized on mammography/ digital breast tomosynthesis (DBT), ultrasound (US), or magnetic resonance imaging (MRI).
Planning and able to undergo breast conservation surgery with planned localization (any localization device is eligible) and intraoperative imaging for the management of invasive breast cancer and/or DCIS
Ability to understand and provide voluntary written informed consent to participate in this study, prior to registration
Exclusion Criteria
Undergoing re-excision for invasive breast cancer or DCIS
Expected to have an excised lumpectomy specimen that is larger than 9 cm x 9 cm x 7 cm
Has a physical or psychiatric illness, condition, or social circumstance that the investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpoints
