Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
July 16, 2019 updated by: Diagnostic Photonics, Inc.
This intraoperative study is a prospective study analyzing specimens from fifty subjects.
Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria.
The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device.
Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
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
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Maryland
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Baltimore, Maryland, United States, 21231
- Johns Hopkins Hospital
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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
Female
Sampling Method
Non-Probability Sample
Study Population
Women with breast cancer undergoing lumpectomy.
Description
Inclusion Criteria:
- Women 18 years of age or older
- Signed informed consent form
- Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
- Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure
Exclusion Criteria:
- Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
- Neoadjuvant systemic therapy
- All T4 tumors
- Previous radiation in the operated breast
- Prior surgical procedure in the same quadrant
- Implants in the operated breast
- Pregnancy
- Lactation
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patients With All Positive/Close Margins Correctly Identified With the Device
Time Frame: 1 week after surgery
|
1 week after surgery
|
|
Number of Margins With False Positive Device Readings
Time Frame: 1 week after surgery
|
1 week after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa Jacobs, Johns Hopkins 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
April 1, 2014
Primary Completion (ANTICIPATED)
February 1, 2020
Study Completion (ANTICIPATED)
March 18, 2020
Study Registration Dates
First Submitted
December 5, 2014
First Submitted That Met QC Criteria
December 8, 2014
First Posted (ESTIMATE)
December 9, 2014
Study Record Updates
Last Update Posted (ACTUAL)
July 18, 2019
Last Update Submitted That Met QC Criteria
July 16, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DxP 2012-02 (Part B)
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.