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

NCT07443579 | Recruiting DMC

• 1 other identifier: 25-49
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast Cancer Recurrence; Post Treatment Surveillance

Keywords

Surveillance Mammography; Mammography View Sequencing; Mammography Technique; Breast Imaging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Image Quality (PGMI Score)

  Following image acquisition (retrospective review after mammography during normal reporting timeframe institutionally)

• Compression Force During Mammography

  During mammography (same study visit)

• Breast Thickness During Mammography

  During mammography (same study visit)

• Mean Glandular Radiation Dose

  During mammography (same study visit)

• Duration of Mammography Procedure

  During mammography (same study visit)

Study Arms (4)

Untreated MLO First

EXPERIMENTAL

Participants undergo surveillance mammography in the following sequence: Untreated mediolateral oblique (MLO), Treated MLO, Untreated craniocaudal (CC), Treated CC.

Procedure: Mammography View Sequencing

Untreated CC First

EXPERIMENTAL

Participants undergo surveillance mammography in the following sequence: Untreated CC, Treated CC, Untreated MLO, Treated MLO.

Procedure: Mammography View Sequencing

Treated MLO First

EXPERIMENTAL

Participants undergo surveillance mammography in the following sequence: Treated MLO, Untreated MLO, Treated CC, Untreated CC.

Procedure: Mammography View Sequencing

Treated CC First

EXPERIMENTAL

Participants undergo surveillance mammography in the following sequence: Treated CC, Untreated CC, Treated MLO, Untreated MLO.

Procedure: Mammography View Sequencing

Interventions

Mammography View Sequencing PROCEDURE

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.

Treated CC First; Treated MLO First; Untreated CC First; Untreated MLO First

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is based on biological sex (female), not gender identity criteria beyond biological sex.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont RCSI Cancer Centre

Beaumont, Dublin, D09V2N0, Ireland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Prof Nuala Healy

CONTACT

+35318093000; nualahealy@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised in a 1:1:1:1 ratio to one of four mammography view sequencing groups. Each group undergoes standard surveillance mammography consisting of mediolateral oblique (MLO) and craniocaudal (CC) views of both treated and untreated breasts, performed in a different predefined sequence. The intervention involves the order in which views are obtained. All participants receive the same imaging views; only the sequence differs. There is no crossover between groups. Analysis will be conducted on an intention-to-treat basis.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 2, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

IE (1)