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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Cancer Recurrence; Post Treatment Surveillance
• Intervention / Treatment: Procedure: Mammography View Sequencing

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof Nuala Healy; Phone Number: +35318093000; Email: nualahealy@rcsi.ie

Study Locations

• Ireland
  • Dublin
    • Beaumont, Dublin, Ireland, D09V2N0
      • Recruiting
      • Beaumont RCSI Cancer Centre
      • Contact: Aisling Hegarty; Phone Number: 0035317977800; Email: Aislinghegarty@rcsi.ie
      • Contact: Aisling Hegarty; Phone Number: 017977800; Email: Aislinghegarty@rcsi.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Female patients aged 18 years or older History of breast cancer treated with breast-conserving surgery (wide local excision) Undergoing first annual surveillance mammogram following completion of surgery and radiotherapy Within five years of breast cancer treatment May have history of whole-breast or partial-breast radiotherapy May have history of axillary surgery Able and willing to provide informed consent

Exclusion Criteria:

Male patients Patients younger than 18 years History of mastectomy History of bilateral wide local excision Lack of capacity to provide informed consent More than five years since completion of breast cancer treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Untreated MLO First; Participants undergo surveillance mammography in the following sequence: Untreated mediolateral oblique (MLO), Treated MLO, Untreated craniocaudal (CC), Treated CC.	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.
Experimental: Untreated CC First; Participants undergo surveillance mammography in the following sequence: Untreated CC, Treated CC, Untreated MLO, Treated MLO.	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.
Experimental: Treated MLO First; Participants undergo surveillance mammography in the following sequence: Treated MLO, Untreated MLO, Treated CC, Untreated CC.	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.
Experimental: Treated CC First; Participants undergo surveillance mammography in the following sequence: Treated CC, Untreated CC, Treated MLO, Untreated MLO.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately before and immediately after mammography (same study visit)
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.	Immediately after mammography (same study visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Following image acquisition (retrospective review after mammography during normal reporting timeframe institutionally)
Compression Force During Mammography	Compression force applied during mammography will be recorded in Newtons from the mammography unit and compared across sequencing groups.	During mammography (same study visit)
Breast Thickness During Mammography	Compressed breast thickness will be recorded in millimetres from the mammography system and compared across sequencing groups.	During mammography (same study visit)
Mean Glandular Radiation Dose	Mean glandular dose (MGD) will be recorded from the mammography unit for each participant and compared across sequencing groups.	During mammography (same study visit)
Duration of Mammography Procedure	Total time taken to complete mammography will be recorded in minutes and compared across sequencing groups.	During mammography (same study visit)

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Breast Imaging; Surveillance Mammography; Mammography View Sequencing; Mammography Technique
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 25-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No