Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode and Quality Assessment of Screening Mammograms

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03928886
• Date of registration: 16/04/2019
• Prospective Registration: No
• Primary sponsor: Parc de Salut Mar
• Public title: Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode and Quality Assessment of Screening Mammograms
• Scientific title: Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode in Asymptomatic Adult Women Undergoing Screening Full-filled Digital Mammography and Quality Evaluation of Screening Mammograms
• Date of first enrolment: December 1, 2017
• Target sample size: 500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03928886
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Screening. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Rodrigo Alcántara, MD

• Name: Rodrigo Alcántara, MD

• Name: Rodrigo Alcántara, MD
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

Inclusion Criteria:

- Women participating in their subsequent round in the breast cancer screening program

- Asymptomatic women scheduled for full-field digital screening mammography

- Have left and right breasts

- Have breast sizes compatible with the dimensions of a 24x29 cm image detector without
anatomical cut-off

- Are able to provide subjective pain scores, per verbal self-report

- Are documented as non-pregnant based on the investigator's medical judgment and in
consideration of local clinical practice standards for evidence of non-pregnancy

- Are able and willing to comply with study procedures

- Are able and willing to provide written informed consent to participate

Exclusion Criteria:

- Have been previously included in this study or are participating in another study
expected to interfere with study procedures or outcomes;

- Have undergone diagnostic or surgical intervention(s) or procedure(s) on either
breast, including breast biopsy, lumpectomy or mastectomy, or reconstruction;

- Are currently undergoing radiotherapy or chemotherapy, or have a history of prior
radiotherapy treatment on either breast;

- Are currently lactating

- Have breast implants.



Age minimum: 50 Years
Age maximum: 69 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Mammography Related Discomfort

Intervention(s)

Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode

Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode

Primary Outcome(s)

Patient discomfort using an 11-point numeric pain rating scale [Time Frame: Immediately following full-field digital mammography breast imaging]

Secondary Outcome(s)

Average glandular dose in mGy [Time Frame: Immediately following full-field digital mammography breast imaging]

Breast thickness in mm [Time Frame: Immediately following full-field digital mammography breast imaging]

Compression force in daN [Time Frame: Immediately following full-field digital mammography breast imaging]

Technical/Clinical quality of mammogram using the PGMI system [Time Frame: Immediately following radiologists analysis]

Secondary ID(s)

2017-7631

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GE Healthcare