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

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier:
NCT01699867
First received: October 2, 2012
Last updated: December 12, 2014
Last verified: December 2014
  Purpose

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 Intervention
Breast Cancer
Device: Optical coherence tomography

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patients With All Positive Margins Correctly Identified With the Device [ Time Frame: one week after surgery ] [ Designated as safety issue: No ]
    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").

  • Number of Margins With False Positive Device Readings [ Time Frame: one week after surgery ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2012
Study Completion Date: April 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Optical coherence tomography
    Optical coherence tomography was used to image ex vivo breast tissue specimens.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier: NCT01699867     History of Changes
Other Study ID Numbers: DxP 2012-02 (Part A)
Study First Received: October 2, 2012
Results First Received: December 5, 2014
Last Updated: December 12, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 27, 2015