Real-time Diagnosis and Visualization of Tumor Margins in Excised Breast Specimens Using Zenith FLIM Diagnostics

Our investigational team has developed a technology to visualize the operative margins in 'real time,' in other words during the operation while the patient is still on the table. While different surgeons use different operative techniques, our technique involves removing the main lumpectomy specimen, marking two of its borders with suture to orient the specimen for correct pathologic evaluation. The FLIM (Fluorescent Lifetime Imaging Microscopy) technique can differentiate between cancerous and noncancerous specimens using a complex algorithm that essentially utilizes a definitive delta between the metabolic activities of diseased and non-diseased tissue. The research coordinator along with the surgeon will be able to insert the lumpectomy specimen followed by the 6 shaved margins (one by one) in a matter of minutes once the specimens have been resected. To be clear, the FLIM analysis will be taking place in- vitro. The device is invitro test and would be tested against the gold standard the pathologist biopsy. FLIM analysis by the surgeon will not take more than several minutes, therefore not adding any significant time for patient to be under anesthesia. All specimens will be removed from the patient's body prior to their evaluation by the FLIM technique. Our team will not be making decisions based on FLIM analysis during this early phase of study. In other words, even if FLIM suggests a positive margin still exists in the body, our team will not act on these results by resecting additional tissue at this stage. FLIM margin results will be compared directly with pathology results for accuracy of the findings.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* A) Age18 and over
* B) EnglishSpeaking
* C) Able to read and understand consent
* D) All patient's candidate for lumpectomy
* E) Recurrent cancer patients requiring lumpectomy
* F) All stages and grades of cancer as long as patient is lumpectomy candidate
* G) Margin1(S)
* H) Margin 2(I)
* I) Margin 3 (M)
* J) Margin 4 (L)
* K) Margin5(P)
* L) Margin 6 (A)

Exclusion Criteria: Exclusion criteria includes any patients with autoimmune disease affecting breast tissue anyone receiving neoadjuvant chemotherapy prior to lumpectomy, any patient undergoing mastectomy.

* A) Extensively damaged tissue
* B) Abnormal tissue(auto immune disease)
* C) Neoadjuvant treated breast
* D) Mastectomy