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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02096185
• Other study ID #: Breast Specimen Imaging Ver3
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 21, 2014
• Last updated: October 19, 2016
• Start date: May 2014
• Est. completion date: May 2017

Study information

• Verified date: November 2015
• Source: Sandwell & West Birmingham Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• 3 dimensional tomosynthesis imaging
Each operative specimen will be imaged twice using each condition
• 2 dimensional digital imaging

Locations

Country	Name	City	State
United Kingdom	Sandwell and West Birmingham Hospitals NHS Trust	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Sandwell & West Birmingham Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'	1 year	No