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Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242277
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
Perimeter Medical Imaging

Tracking Information
First Submitted Date January 23, 2020
First Posted Date January 27, 2020
Last Update Posted Date January 27, 2020
Estimated Study Start Date March 20, 2020
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2020)
WF-OCT image acquisition of excised lumpectomy tissue margins [ Time Frame: 1 year ]
This is a data collection study. The primary outcome is the collection of WF-OCT images of excised lumpectomy tissue margins.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
Official Title Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue for Evaluation of a Computer-aided Detection Tool, ImgAssist™.
Brief Summary This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology. Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Consented patients meeting eligibility criteria, undergoing breast conservation surgery.
Condition Breast Cancer Female
Intervention Device: Investigational WF-OCT device
Excised lumpectomy tissue will be imaged on an investigational WF-OCT device
Study Groups/Cohorts WF-OCT imaging of excised breast lumpectomy tissue
Excised lumpectomy tissue from all consented patients will be imaged on an investigational OCT-based device. No clinical decisions will be made based on the images acquired.
Intervention: Device: Investigational WF-OCT device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 23, 2020)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Female
  • Age 18 years or older
  • Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery
  • May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation)
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Metastatic cancer (Stage IV)
  • Lobular carcinoma as primary diagnosis
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rochelle Keen, RTR(M) 7179892493 rkeen@perimetermed.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04242277
Other Study ID Numbers PER-19-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Perimeter Medical Imaging
Study Sponsor Perimeter Medical Imaging
Collaborators Cancer Prevention Research Institute of Texas
Investigators
Principal Investigator: Savitri Krishnamurthy, MD M.D. Anderson Cancer Center
PRS Account Perimeter Medical Imaging
Verification Date January 2020