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临床试验/NCT04009278
NCT04009278已完成不适用

Self-compression Mammography in Clinical Practice: A Randomized Clinical Trial Compared to Standard Compression Mammography

Azienda USL Reggio Emilia - IRCCS2 个研究点 分布在 1 个国家目标入组 502 人开始时间: 2018年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
502
试验地点
2
主要终点
Image quality: radiographers' scale.

研究概览

简要总结

Every year millions of mammograms are performed worldwide, representing the primary examination for the early diagnosis of breast cancer. Despite continuous advances in medicine and technology, an aspect of mammography has not changed in over fifty years: the breast is still compressed on the detector because this allows to reduce the thickness of the breast thus improving the quality of the diagnostic image and reducing the dose of radiation necessary to obtain a clear image. Many women perceive as painful this compression, including women who have been treated for breast cancer.

Pain can discourage asymptomatic women to present themselves periodically to screening mammography, while an increasing number of women in follow-up after conservative surgery have to withstand the pain caused by mammography.

Some studies mention various factors that are responsible for pain when performing mammography: breast sensitivity, anxiety level, expected pain and staff attitude. Some studies have also identified breast density, breast volume and menstrual phase as other influencing factors, although not all studies support these hypothesis. The technical characteristics of the equipment can greatly affect annoyance, sense of oppression, pain. The technological proposals to reduce the discomfort of the patients concern various items: flexible compressors, self-compression devices under the supervision of the technician who performs the positioning and the minimum initial compression, environmental factors such as equipment noise reduction, chromatic, sound and sensory effects (eg: aromatic diffusers).

The aim of our study is to evaluate the effectiveness of the self-compression compared to the standard one, in reducing annoyance, a sense of oppression and pain, and to evaluate the difference of the average glandular dose given to the woman for each projection.

Self-compression may help reaching better compression tolerating the discomfort and pain induced thus allowing to achieve a lower thickness, a lower glandular dose and a better image.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Each patient is identified in the study by a Subject Number (Subject No.), that is assigned when the patient is registered for mammography and is retained as the primary identifier for the patient throughout his/her entire participation in the trial.

The allocation to experimental or control arm ill be open to patients and the research staff.

The Image quality evaluations of Radiologists and the Radiographers are performed blindly.

入排标准

年龄范围
18 Months 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women in follow-up after surgery
  • Symptomatic women undergoing mammography
  • Early diagnosis in asymptomatic women outside the organized screening program (these women are predominantly aged 40-44 / 75-85)
  • Women with familiar risk

排除标准

  • Augmentation prostheses
  • Women in screening with active invitation
  • Physical impossibility to use the self-compression command
  • Inability to provide consent

结局指标

主要结局

Image quality: radiographers' scale.

时间窗: This outcome is measured at the baseline mammography.

Radiographers evaluate the image quality after exam with a radiographer specific 3-item scale (contrast, resolution, compression) on a 0 to 5 point scale. Higher values mean better quality.

Image quality: radiologists' scale.

时间窗: This outcome is measured at the baseline mammography.

Radiologists evaluate the image quality after exam a radiologist specific 3-item scale (contrast, resolution, compression) on a 0 to 5 point scale. Higher values mean better quality.

Average glandular dose administered (mSv)

时间窗: This outcome is measured at the baseline mammography.

Average glandular dose administered during mammography is automatically computed by the machine according to an algorithm using the data on the quantity of radiation emitted and the radiation captured by the detector.

次要结局

  • Discomfort(Discomfort will be measured just after the baseline mammography.)
  • Memory of pain in previous mammography(before the follow up mammography, i.e. approximately 1 year after baseline mammography)
  • Breast thickness at the time of exposure (cm)(This outcome is measured at the baseline mammography.)
  • Pain during compression(pain will be evaluated immediately after baseline mammography execution)
  • Execution time of the exam:(This outcome is measured at the baseline mammography.)
  • Anxiety(Anxiety will be measured just before the baseline mammography and before the follow up mammography, i.e. approximately 1 year after baseline mammography.)
  • Maximum compression (daN)(This outcome is measured at the baseline mammography.)
  • Participation in follow up mammography(1 year (+/- 2 months) after baseline mammography)

研究者

发起方
Azienda USL Reggio Emilia - IRCCS
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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