About this trial
This prospective, single-centre, parallel-group randomised controlled trial evaluates the optimal sequencing of mammography views in women with a history of breast cancer undergoing surveillance mammography. Women treated with breast-conserving surgery within the previous five years will be randomised 1:1:1:1 to one of four mammography view sequencing groups.
The primary objective is to compare patient-reported pain and satisfaction across sequencing groups. Secondary objectives include comparison of image quality (PGMI scoring), compression force, and breast thickness.
A total of 400 participants will be enrolled at Beaumont Hospital Breast Care Centre over 2.5 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Mammography View Sequencing
Procedure/SurgeryStandard surveillance mammography consisting of MLO and CC views of both treated and untreated breasts. Participants are randomised to one of four predefined sequences determining the order in which views are obtained. No additional imaging beyond standard of care is performed.
Treatment groups
Trial outcomes
Primary outcomes
Change in Patient-Reported Pain Score During Mammography
Pain will be measured using a 10-point Visual Analogue Scale (VAS). Pain scores will be recorded immediately prior to mammography and immediately following completion of mammography. The primary analysis will compare post-procedure pain scores across the four randomised sequencing groups.
Patient Satisfaction Following Mammography
Patient satisfaction will be assessed immediately after mammography using a structured electronic questionnaire administered via MS Forms. Responses will be compared across the four sequencing groups.
Secondary outcomes
Image Quality (PGMI Score)
Image quality will be assessed retrospectively using the PGMI (Perfect, Good, Moderate, Inadequate) scoring system by two radiologists. PGMI scores will be compared across sequencing groups.
Compression Force During Mammography
Compression force applied during mammography will be recorded in Newtons from the mammography unit and compared across sequencing groups.
Breast Thickness During Mammography
Compressed breast thickness will be recorded in millimetres from the mammography system and compared across sequencing groups.
Mean Glandular Radiation Dose
Mean glandular dose (MGD) will be recorded from the mammography unit for each participant and compared across sequencing groups.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.