NCT07443579

Optimal Mammography View Sequencing in Women With a History of Breast Cancer Undergoing Surveillance Mammography

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Women with a history of breast cancer routinely undergo annual surveillance mammography following breast-conserving surgery and radiotherapy. Standard mammography includes mediolateral oblique (MLO) and craniocaudal (CC) views of each breast. However, there is limited evidence regarding whether the order in which these views are obtained affects patient experience or image quality. This study randomises 400 women (1:1:1:1) to four different view sequencing protocols: 1. Untreated MLO --- Treated MLO --- Untreated CC --- Treated CC 2. Untreated CC --- Treated CC --- Untreated MLO --- Treated MLO 3. Treated MLO --- Untreated MLO --- Treated CC --- Untreated CC 4. Treated CC --- Untreated CC --- Treated MLO --- Untreated MLO Pain is assessed using a visual analogue scale (VAS) before and after mammography. Patient satisfaction is measured using a post-procedure questionnaire. Image quality will be assessed retrospectively using PGMI scoring by two radiologists. Compression force and breast thickness will also be recorded. The study uses an intention-to-treat analysis framework.

Conditions

• Breast Cancer
• Breast Cancer Recurrence
• Post Treatment Surveillance

Interventions

Type	Name	Description
PROCEDURE	Mammography View Sequencing	Standard 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.

Timeline

• Start date: 2026-02-24
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: Ireland