Is Any Additional Information Gained Regarding Margins Using 3D Tomosynthesis Vs 2D Conventional Digital Imaging When Imaging Operative Breast Specimens?

Not Applicable

• Conditions: Breast Cancer
• Interventions: Radiation: 3 dimensional tomosynthesis imaging; Radiation: 2 dimensional digital imaging

• Registration Number: NCT02096185
• Lead Sponsor: Sandwell & West Birmingham Hospitals NHS Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Study Start: 2014-05
• Status Verified: 2015-11
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Patient requires surgery to remove breast cancer and operative specimen needs to be x-rayed

Exclusion Criteria

• Patients with breast cancer who need mastectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3 dimensional tomosynthesis imaging	3 dimensional tomosynthesis imaging	Breast specimen to be x-rayed using both conditions 3 dimensional tomosynthesis imaging 2 dimensional conventional digital imaging
2 dimensional digital imaging	2 dimensional digital imaging	Breast specimens to be x-rayed under both conditions 3 dimensional tomosynthesis imaging 2 dimensional digital imaging

Primary Outcome Measures

Name	Time	Method
Shortest distance in mm from visible lesion to specimen margin	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'

Trial Locations

Locations (1)

Sandwell and West Birmingham Hospitals NHS Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom