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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01699867
First Posted: October 4, 2012
Last Update Posted: January 6, 2015
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.
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Diagnostic Photonics, Inc.
Results First Submitted: December 5, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Breast Cancer
Intervention: Device: Optical coherence tomography

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Optical Coherence Tomography (Single-arm) Specimens from all patients were evaluated by optical coherence tomography.

Participant Flow:   Overall Study
    Optical Coherence Tomography (Single-arm)
STARTED   50 
COMPLETED   47 
NOT COMPLETED   3 
Screening Failure                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
47 patients completed the study. 1 patient was excluded from the analysis due to insufficient images in all specimens (did not meet protocol specifications).

Reporting Groups
  Description
Optical Coherence Tomography (Single-arm) Specimens from all patients were evaluated by optical coherence tomography.

Baseline Measures
   Optical Coherence Tomography (Single-arm) 
Overall Participants Analyzed 
[Units: Participants]
 46 
Age 
[Units: Years]
Mean (Full Range)
 62 
 (27 to 81) 
Gender 
[Units: Participants]
 
Female   46 
Male   0 


  Outcome Measures
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1.  Primary:   Patients With All Positive Margins Correctly Identified With the Device   [ Time Frame: one week after surgery ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa K. Jacobs, M.D.
Organization: Johns Hopkins Medicine
phone: 410-502-0880
e-mail: ljacob14@jhmi.edu



Responsible Party: Diagnostic Photonics, Inc.
ClinicalTrials.gov Identifier: NCT01699867     History of Changes
Other Study ID Numbers: DxP 2012-02 (Part A)
First Submitted: October 2, 2012
First Posted: October 4, 2012
Results First Submitted: December 5, 2014
Results First Posted: December 12, 2014
Last Update Posted: January 6, 2015