Status:
SUSPENDED
Real-time Diagnosis and Visualization of Tumor Margins in Excised Breast Specimens Using Zenith FLIM Diagnostics
Lead Sponsor:
Laser LabCorp
Conditions:
Oncology
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 surg...
Detailed Description
The purpose of this study is to evaluate the effectiveness of the investigational Zenith FLIM Diagnostics imaging device that's modality is a direct support during lumpectomy cancer surgery to achieve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 2 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04683120
Start Date
December 15 2021
End Date
November 2 2022
Last Update
June 30 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Laser LabCorp
New York, New York, United States, 10019