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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mrs Jennifer Waldron, Sandwell & West Birmingham Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT02096185
First received: March 21, 2014
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention
Breast Cancer
Radiation: 3 dimensional tomosynthesis imaging
Radiation: 2 dimensional digital imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Sandwell & West Birmingham Hospitals NHS Trust:

Primary Outcome Measures:
  • Shortest distance in mm from visible lesion to specimen margin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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'


Enrollment: 50
Study Start Date: May 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096185

Locations
United Kingdom
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham, West Midlands, United Kingdom, B18 7QH
Sponsors and Collaborators
Sandwell & West Birmingham Hospitals NHS Trust
Investigators
Principal Investigator: Jennifer Waldron Sandwell & West Birmingham Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Mrs Jennifer Waldron, Consultant Radiographer, Sandwell & West Birmingham Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02096185     History of Changes
Other Study ID Numbers: Breast Specimen Imaging Ver3
Study First Received: March 21, 2014
Last Updated: March 26, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Sandwell & West Birmingham Hospitals NHS Trust:
Breast cancer
Surgery
Specimen imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014