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

NCT04683120 | Suspended DMC

• 1 other identifier: Laser LabCorp #001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Oncology; Breast Cancer; Cancer Diagnosis; Margins of Excision; Margins, Tumor-Free

Keywords

Oncology; Breast Cancer; Zenith FLIM Diagnostics; FLIM; Tumor; Margin Assessment

Outcome Measures

Primary Outcomes (1)

• Tumor Distance From Margins in all 6 Dimensions

  Tumor distance from margin in all 6 dimensions compared to final histopathologic diagnosis/confirmation in testing for accuracy of the Zenith FLIM.

  5-10 minutes after tumor and margins are extricated from body

Study Arms (1)

Single Arm Study

EXPERIMENTAL

This is a single arm study, which will involve all patients qualifying for Breast Conservation Therapy as a part of their breast cancer management excluding patients undergoing neoadjuvant therapy for inoperable disease.

Diagnostic Test: Zenith FLIM Diagnostics

Interventions

Zenith FLIM Diagnostics DIAGNOSTIC_TEST

In-vitro

Single Arm Study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Laser LabCorp: lead

Study Sites (1)

Laser LabCorp

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Brad Schoengood

  Laser LabCorp

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 24, 2020
• Study Start: December 15, 2021
• Primary Completion: August 3, 2022
• Study Completion: November 2, 2022
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

US (1)