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Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01699867
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : December 12, 2014
Last Update Posted : January 6, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.

Condition or disease Intervention/treatment
Breast Cancer Device: Optical coherence tomography

Study Design

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
Study Start Date : December 2012
Primary Completion Date : May 2013
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Device: Optical coherence tomography
    Optical coherence tomography was used to image ex vivo breast tissue specimens.

Outcome Measures

Primary Outcome Measures :
  1. Patients With All Positive Margins Correctly Identified With the Device [ Time Frame: one week after surgery ]
    In this study, a patient had "positive margins" if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, "tumor on ink").

  2. Number of Margins With False Positive Device Readings [ Time Frame: one week after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with breast cancer undergoing lumpectomy
Criteria

Inclusion Criteria:

  1. Women 18 years of age or older
  2. Signed informed consent form
  3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
  4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure

Exclusion Criteria:

  1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
  2. Neoadjuvant systemic therapy
  3. All T4 tumors
  4. Previous radiation in the operated breast
  5. Prior surgical procedure in the same quadrant
  6. Implants in the operated breast
  7. Pregnancy
  8. Lactation
  9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699867


Locations
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Diagnostic Photonics, Inc.
Johns Hopkins University
Investigators
Principal Investigator: Lisa K Jacobs, M.D. Johns Hopkins University
More Information

Responsible Party: Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier: NCT01699867     History of Changes
Other Study ID Numbers: DxP 2012-02 (Part A)
First Posted: October 4, 2012    Key Record Dates
Results First Posted: December 12, 2014
Last Update Posted: January 6, 2015
Last Verified: December 2014

Keywords provided by Diagnostic Photonics, Inc.:
lumpectomy
breast cancer
optical coherence tomography
tumor margin
imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases