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

March 21, 2014
March 26, 2014
May 2014
November 2014   (final data collection date for primary outcome measure)
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'
Accuracy of lesion to margin measurement using both imaging conditions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02096185 on ClinicalTrials.gov Archive Site
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Is Any Additional Information Gained Regarding Margins Using 3D Tomosynthesis Vs 2D Conventional Digital Imaging When Imaging Operative Breast Specimens?
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

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.

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Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Breast Cancer
  • Radiation: 3 dimensional tomosynthesis imaging
    Each operative specimen will be imaged twice using each condition
  • Radiation: 2 dimensional digital imaging
  • Experimental: 3 dimensional tomosynthesis imaging
    Breast specimen to be x-rayed using both conditions 3 dimensional tomosynthesis imaging 2 dimensional conventional digital imaging
    Intervention: Radiation: 3 dimensional tomosynthesis imaging
  • Experimental: 2 dimensional digital imaging
    Breast specimens to be x-rayed under both conditions 3 dimensional tomosynthesis imaging 2 dimensional digital imaging
    Intervention: Radiation: 2 dimensional digital imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Female
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT02096185
Breast Specimen Imaging Ver3
No
Mrs Jennifer Waldron, Sandwell & West Birmingham Hospitals NHS Trust
Sandwell & West Birmingham Hospitals NHS Trust
Not Provided
Principal Investigator: Jennifer Waldron Sandwell & West Birmingham Hospitals NHS Trust
Sandwell & West Birmingham Hospitals NHS Trust
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP