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

NCT02096185 | Unknown

• 1 other identifier: Breast Specimen Imaging Ver3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Surgery; Specimen imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

3 dimensional tomosynthesis imaging

EXPERIMENTAL

Breast specimen to be x-rayed using both conditions 3 dimensional tomosynthesis imaging 2 dimensional conventional digital imaging

Radiation: 3 dimensional tomosynthesis imaging

2 dimensional digital imaging

EXPERIMENTAL

Breast specimens to be x-rayed under both conditions 3 dimensional tomosynthesis imaging 2 dimensional digital imaging

Radiation: 2 dimensional digital imaging

Interventions

3 dimensional tomosynthesis imaging RADIATION

Each operative specimen will be imaged twice using each condition

3 dimensional tomosynthesis imaging

2 dimensional digital imaging RADIATION

2 dimensional digital imaging

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with breast cancer who need mastectomy

Sponsors & Collaborators

• Sandwell & West Birmingham Hospitals NHS Trust: lead

Study Sites (1)

Sandwell and West Birmingham Hospitals NHS Trust

Birmingham, West Midlands, B18 7QH, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Waldron

  Sandwell & West Birmingham Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Radiographer

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 21, 2016

Record last verified: 2015-11

Locations

GB (1)