Exploratory Study Comparing ClearSight System 2D Map to Post Surgery Histopathological Analysis in Lumpectomy
Clinical Study of the ClearSight™ System to Evaluate the Ability to Distinguish Malignant From Non-malignant Breast Tissue by Comparing MR Measurements of Freshly Excised Breast Tissue to Histopathology
1 other identifier
observational
220
2 countries
5
Brief Summary
Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 25, 2016
CompletedFirst Posted
Study publicly available on registry
February 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedFebruary 8, 2023
February 1, 2023
2.2 years
January 25, 2016
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Malignant and non-malignant breast tissues will be assessed by ClearSight™ to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery using histopathological assessment as reference
12 months
Study Arms (1)
ClearSight™ System
To assess the ability of the ClearSight™ System to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery when compared to histopathological assessment.
Interventions
comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.
Eligibility Criteria
Patients diagnosed with primary breast cancer
You may qualify if:
- Women histologically diagnosed with carcinoma of the breast, scheduled for primary lumpectomy (partial mastectomy) procedure.
- Age ≥18.
- Signed ICF
You may not qualify if:
- Prior surgical procedure in the same breast within 12 months prior to the surgery date.
- Recurrent breast cancer surgery.
- Neoadjuvant chemotherapy.
- Previous radiation therapy to the operated breast.
- Pregnant / breast feeding.
- Participating in any other study that might affect results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
The George Washington University Hospital (GWU)
Washington D.C., District of Columbia, 20037, United States
Kaplan Medical Center
Rehovot, Israel
Assuta Medical Center
Tel Aviv, Israel
Assaf Harofeh Medical Center
Ẕerifin, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Christine B. Teal, Dr.
The George Washington University (GWU)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2016
First Posted
February 10, 2016
Study Start
October 1, 2015
Primary Completion
December 1, 2017
Study Completion
November 1, 2018
Last Updated
February 8, 2023
Record last verified: 2023-02