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临床试验/NCT02096185
NCT02096185Unknown不适用

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

Sandwell & West Birmingham Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Shortest distance in mm from visible lesion to specimen margin

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • •Patients with breast cancer who need mastectomy

研究组 & 干预措施

3 dimensional tomosynthesis imaging

Experimental

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

干预措施: 3 dimensional tomosynthesis imaging (Radiation)

2 dimensional digital imaging

Experimental

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

干预措施: 2 dimensional digital imaging (Radiation)

结局指标

主要结局

Shortest distance in mm from visible lesion to specimen margin

时间窗: 1 year

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'

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Waldron

Consultant Radiographer

Sandwell & West Birmingham Hospitals NHS Trust

研究点 (1)

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