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
|Condition or disease||Intervention/treatment|
|Breast Cancer Female||Device: Investigational WF-OCT device|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|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|
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
- 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.
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
|Contact: Rochelle Keen, RTR(M)||firstname.lastname@example.org|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Contact: Rochelle Keen 717-989-2493 email@example.com|
|Principal Investigator:||Savitri Krishnamurthy, MD||M.D. Anderson Cancer Center|