CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 502 enrolled
Drug / intervention
Self compression armother
Likely dose
Not stated in record
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Search/NCT04009278
NCT04009278N/ACompleted

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

Azienda USL Reggio Emilia - IRCCS·interventional·Posted Jul 5, 2019·Updated Jun 12, 2025

In Brief

A clinical study evaluating Self compression arm for Mammography and Breast Cancer. Completed, enrolled 502 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 5, 2019
Enrollment StartJan 25, 2018
Primary CompletionJul 31, 2019
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.0 years ago

Interventions

Self compression armother

The optimal compression level up will be under the supervision of the radiographer who will interpose the compression when a level is reached beyond which there is no further reduction in thickness (15 daN). If the woman stops at a compression of less than 10 daN and that the radiographer considers not adequate to perform a quality mammogram, the radiographer will perform the compression in conventional mode and record the passage of compression mode.