None listed
Conditions
Brief summary
The purpose of this study is to determine if an imaging method called confocal endomicroscopy can accurately identify the margins of breast cancer during surgery. Who is it for? You may be eligible for this study if you are an adult who has breast cancer and is undergoing primary wide local excision with cavity shave. Study details Participants in this study will undergo their usual treatment with the addition of contrast agent, additional imaging during surgery, and additional imaging of the tumour in pathology. During this procedure the surgeon will take some cancerous tissue and perform the imaging test and then send the tissue for standard pathology tests. There will be no additional involvement from participants
Interventions
During the lumpectomy procedure, patients will be injected with IV fluorescein sodium (7.5ml of 10% solution). The endomicroscope will be used to image the inside of the cavity after removal of the excised lump. The surgeon will be blinded to the images from the endomicroscope for this procedure and imaging will not affect patient standard of care. Tissue excised during wide local excision with cavity shaves will be topically stained with fluorescein, acriflavine and acridine orange, and then imaged with a handheld confocal endomicroscope. Images will be collected and assessed for potential involved margins for each piece of tissue excised during the procedure. Tissue will then be fixed and processed using standard pathology processes. The ability of confocal endomicroscopy to identify potential involved margins will be assessed against the results from pathology. The surgeon and pathologists will be blinded to the confocal imaging results, so there will be no deviation from normal standard of care for patients in this study. The in vivo and ex vivo confocal endomicroscopy will be done by an Optiscan technician who is trained in the use of the endomicroscope.
Sponsors
Eligibility
Inclusion criteria
Patients over age 18 years with breast cancer undergoing primary wide local excision with cavity shave (“WLE + CS”)
Exclusion criteria
Patients undergoing re-excision after prior wide local excision (“WLE”). Patients without study consent.