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Trial record 2 of 7 for:    breast cancer optical margins assessment

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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02313116
First Posted: December 9, 2014
Last Update Posted: December 14, 2016
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.
Information provided by (Responsible Party):
Diagnostic Photonics, Inc.
  Purpose
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.

Condition Intervention
Breast Cancer Device: Interferometric Synthetic Aperture Microscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

Resource links provided by NLM:


Further study details as provided by Diagnostic Photonics, Inc.:

Primary Outcome Measures:
  • Patients With All Positive/Close Margins Correctly Identified With the Device [ Time Frame: 1 week after surgery ]
  • Number of Margins With False Positive Device Readings [ Time Frame: 1 week after surgery ]

Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Interferometric Synthetic Aperture Microscopy
    Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens.
    Other Name: Optical Coherence Tomography
  Eligibility

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): NCT02313116


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Diagnostic Photonics, Inc.
Investigators
Principal Investigator: Lisa Jacobs Johns Hopkins University
  More Information

Responsible Party: Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier: NCT02313116     History of Changes
Other Study ID Numbers: DxP 2012-02 (Part B)
First Submitted: December 5, 2014
First Posted: December 9, 2014
Last Update Posted: December 14, 2016
Last Verified: December 2016

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