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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

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.

Condition or disease Intervention/treatment
Breast Cancer Female Device: Investigational WF-OCT device

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue for Evaluation of a Computer-aided Detection Tool, ImgAssist™.
Estimated Study Start Date : March 20, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: Investigational WF-OCT device
Excised lumpectomy tissue will be imaged on an investigational WF-OCT device




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consented patients meeting eligibility criteria, undergoing breast conservation surgery.
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

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): NCT04242277


Contacts
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Contact: Rochelle Keen, RTR(M) 7179892493 rkeen@perimetermed.com

Locations
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United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Rochelle Keen    717-989-2493    rkeen@perimetermed.com   
Sponsors and Collaborators
Perimeter Medical Imaging
Cancer Prevention Research Institute of Texas
Investigators
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Principal Investigator: Savitri Krishnamurthy, MD M.D. Anderson Cancer Center
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Responsible Party: Perimeter Medical Imaging
ClinicalTrials.gov Identifier: NCT04242277    
Other Study ID Numbers: PER-19-03
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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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