An interventional study of 3 dimensional tomosynthesis imaging and 2 dimensional digital imaging in Breast Cancer, sponsored by Sandwell & West Birmingham Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to female participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by Sandwell & West Birmingham Hospitals NHS Trust · Not applicable, Interventional, and Diagnostic
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sandwell & West Birmingham Hospitals NHS Trust is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Breast specimen to be x-rayed using both conditions 3 dimensional tomosynthesis imaging 2 dimensional conventional digital imaging
Radiation: 3 dimensional tomosynthesis imaging
Breast specimens to be x-rayed under both conditions 3 dimensional tomosynthesis imaging 2 dimensional digital imaging
Radiation: 2 dimensional digital imaging
Each operative specimen will be imaged twice using each condition
Shortest distance in mm from visible lesion to specimen margin
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'
Time frame: 1 year
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Sandwell & West Birmingham Hospitals NHS Trust