Is Any Additional Information Gained Regarding Margins Using 3D Tomosynthesis Vs 2D Conventional Digital Imaging When Imaging Operative Breast Specimens?
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|ClinicalTrials.gov Identifier: NCT02096185|
Recruitment Status : Unknown
Verified November 2015 by Jennifer Waldron, Sandwell & West Birmingham Hospitals NHS Trust.
Recruitment status was: Enrolling by invitation
First Posted : March 26, 2014
Last Update Posted : October 21, 2016
Patients who are diagnosed with breast cancer will have surgery to remove the tumour. Where this is a local excision not mastectomy, the tissue removed is sent for x-ray imaging to assess that the abnormality has been removed and give an estimation of the distance from lesion to specimen edge. This allows the surgeon to decide whether to remove more tissue or not at the time. This study is designed to compare whether more accurate information about lesion to margin measurement can be obtained using 3 dimensional tomosynthesis imaging compared to 2 dimensional conventional digital imaging which is the type of imaging currently used. This has the potential to prevent some patients requiring a second operation to remove more tissue if the margins of the specimen are still involved with tumour.
The study involves x-raying the specimen under both conditions when it arrives from theatre. Only the 2D image will be reviewed at the time as is current practice. The 3D image will be reviewed later and the measurements for lesion to specimen margin compared. The lesion to margin measurement as recorded by the pathologist will be taken as the 'gold standard' and the imaging measurements will also be compared to that.
In theory, the use of 3D tomosynthesis should allow more accurate lesion to margin measurement because 3D can provide better visualisation of the lesion edges by removing the effect of superimposed tissue.
The hypothesis states that the use of 3 dimensional tomosynthesis imaging should provide better lesion visualisation compared to 2 dimensional conventional digital imaging thus allowing more accurate lesion to margin measurement.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: 3 dimensional tomosynthesis imaging Radiation: 2 dimensional digital imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Is Any Additional Information Gained Regarding Lesion to Margin Measurement Using 3D Tomosynthesis Imaging Versus 2D Conventional Digital Imaging When Imaging Specimens of Breast Tissue Removed at Therapeutic Surgery|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||May 2017|
Experimental: 3 dimensional tomosynthesis imaging
Breast specimen to be x-rayed using both conditions 3 dimensional tomosynthesis imaging 2 dimensional conventional digital imaging
Radiation: 3 dimensional tomosynthesis imaging
Each operative specimen will be imaged twice using each condition
Experimental: 2 dimensional digital imaging
Breast specimens to be x-rayed under both conditions 3 dimensional tomosynthesis imaging 2 dimensional digital imaging
Radiation: 2 dimensional digital imaging
- Shortest distance in mm from visible lesion to specimen margin [ Time Frame: 1 year ]2D conventional digital imaging - measured at time of surgery and info relayed to surgeon in theatre 3D tomosynthesis imaging - measured later with operator blinded to the 2D measurement Pathological measurement - final measurement used as the 'gold standard'
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): NCT02096185
|Sandwell and West Birmingham Hospitals NHS Trust|
|Birmingham, West Midlands, United Kingdom, B18 7QH|
|Principal Investigator:||Jennifer Waldron||Sandwell & West Birmingham Hospitals NHS Trust|