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

Sandwell & West Birmingham Hospitals NHS Trust

Status: Unknown

Conditions: Breast Cancer

Treatments: Radiation: 3 dimensional tomosynthesis imaging; Radiation: 2 dimensional digital imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02096185

Breast Specimen Imaging Ver3

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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50 participants in 2 patient groups

3 dimensional tomosynthesis imaging

Experimental group

Description:

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

Treatment:

Radiation: 3 dimensional tomosynthesis imaging

2 dimensional digital imaging

Experimental group

Description:

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

Treatment:

Radiation: 2 dimensional digital imaging