NCT04009278: Pristina2/TR

Self-compression Mammography in Clinical Practice

Completed NA Last updated 12 June 2025

What this trial tests

NA trial testing Self compression arm in Mammography in 502 participants. Completed in 31 December 2020.

Timeline

25 January 2018

Primary endpoint
31 July 2019

31 December 2020

Quick facts

Lead sponsor	Azienda USL Reggio Emilia - IRCCS
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	502
Start date	25 January 2018
Primary completion	31 July 2019
Estimated completion	31 December 2020
Sites	1 location across Italy

Drugs / interventions tested

• Self compression arm

Conditions studied

• Mammography — all drugs for Mammography →
• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Azienda USL Reggio Emilia - IRCCS — full company profile →

Who can join

18 Months and older, female only, with Mammography or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Patient-centred care with self-compression mammography in clinical practice: a randomized trial compared to standard compression.
   Iotti V, Giorgi Rossi P, Canovi L, Guberti M, et al · · 2023 · cited 2× · PMID 35869315 · DOI 10.1007/s00330-022-09002-z