Skip to main content
OpenTrials
Completed

NCT Number: NCT04009278

Self-compression Mammography in Clinical Practice

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 month and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laura Canovi

Reggio Emilia, RE, 42123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Self compression arm

Other

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.

Primary outcomes

  1. Average glandular dose administered (mSv)

    Time frame: 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.

  2. Image quality: radiographers' scale.

    Time frame: 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.

  3. Image quality: radiologists' scale.

    Time frame: 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.

Secondary outcomes

  1. Breast thickness at the time of exposure (cm)

    Time frame: This outcome is measured at the baseline mammography.

    Breast thickness is measured automatically by the machine. This endpoint will be evaluated using single exposure as statistical unit, taking into account the autocorrelation of the 4 exposures in the same woman.

  2. Maximum compression (daN)

    Time frame: This outcome is measured at the baseline mammography.

    Compression is measured automatically by the machine. This endpoint will be evaluated using single exposure as statistical unit, taking into account the autocorrelation of the 4 exposures in the same woman.

  3. Pain during compression

    Time frame: pain will be evaluated immediately after baseline mammography execution

    visual assessment scale

  4. Memory of pain in previous mammography

    Time frame: before the follow up mammography, i.e. approximately 1 year after baseline mammography

    visual assessment scale

  5. Anxiety

    Time frame: Anxiety will be measured just before the baseline mammography and before the follow up mammography, i.e. approximately 1 year after baseline mammography.

    questionnaire: State Trait Anxiety Inventory for adults - form Y (D. Spielberger).

    The scale has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety.

  6. Discomfort

    Time frame: Discomfort will be measured just after the baseline mammography.

    Discomfort will be measured with a one-item scale with five-point range (no, slight, moderate, considerable and severe discomfort).

  7. Execution time of the exam:

    Time frame: This outcome is measured at the baseline mammography.

    We evaluate: - total time (from randomization to close examination). Times are automatically registered by the radiology information system.

    • Second breast time (from the acquisition of the second right breast projection to the acquisition of the second left breast projection)
  8. Participation in follow up mammography

    Time frame: 1 year (+/- 2 months) after baseline mammography

    Number of women presenting to follow up mammography (1 year +/-2 months)/number of recruited women referred to follow up mammography after 1 year

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Acronym: Pristina2/TR

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.