Trial record 2 of 9 for:    breast cancer optical margins assessment

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Diagnostic Photonics, Inc.
Sponsor:
Information provided by (Responsible Party):
Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier:
NCT02313116
First received: December 5, 2014
Last updated: December 8, 2014
Last verified: December 2014
  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 ] [ Designated as safety issue: No ]
  • Number of Margins With False Positive Device Readings [ Time Frame: 1 week after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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

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: NCT02313116

Contacts
Contact: Dene Palazzi 443-287-8610 dnoppen1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21231
Contact: Dene Palazzi    443-287-8610    dnoppen1@jhmi.edu   
Principal Investigator: Lisa K Jacobs, M.D.         
Sponsors and Collaborators
Diagnostic Photonics, Inc.
Investigators
Principal Investigator: Lisa Jacobs Johns Hopkins Medicine
  More Information

No publications provided

Responsible Party: Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier: NCT02313116     History of Changes
Other Study ID Numbers: DxP 2012-02 (Part B)
Study First Received: December 5, 2014
Last Updated: December 8, 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 March 26, 2015