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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRoyal College of Surgeons, Ireland

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mammography View Sequencing

    Procedure/Surgery

    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.

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Untreated MLO FirstExperimental treatment 1 intervention
Group B: Untreated CC FirstExperimental treatment 1 intervention
Group C: Treated MLO FirstExperimental treatment 1 intervention
Group D: Treated CC FirstExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately before and immediately after mammography (same study visit)
2

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.

Time frame
Immediately after mammography (same study visit)

Secondary outcomes

1

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.

Time frame
Following image acquisition (retrospective review after mammography during normal reporting timeframe institutionally)
2

Compression Force During Mammography

Compression force applied during mammography will be recorded in Newtons from the mammography unit and compared across sequencing groups.

Time frame
During mammography (same study visit)
3

Breast Thickness During Mammography

Compressed breast thickness will be recorded in millimetres from the mammography system and compared across sequencing groups.

Time frame
During mammography (same study visit)
4

Mean Glandular Radiation Dose

Mean glandular dose (MGD) will be recorded from the mammography unit for each participant and compared across sequencing groups.

Time frame
During mammography (same study visit)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.