An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients
May 14, 2020 updated by: Duke University
Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.
Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues.
We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds.
In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment.
The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
485
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27708
- Duke University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of Breast Cancer
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Reduction Mammoplasty
Patients undergoing reduction mammoplasty
|
|
|
Experimental: Mastectomy
Patients undergoing mastectomy
|
|
|
Experimental: Lumpectomy
Patients undergoing a lumpectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of the optical signatures of breast tissue.
Time Frame: Day of procedure
|
The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.
|
Day of procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nimmi Ramanujam, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
August 13, 2008
First Submitted That Met QC Criteria
August 13, 2008
First Posted (Estimate)
August 14, 2008
Study Record Updates
Last Update Posted (Actual)
May 15, 2020
Last Update Submitted That Met QC Criteria
May 14, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00007857
- 1R01EB011574-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.