Beaumont RCSI Cancer Centre
Beaumont, Dublin, D09V2N0, Ireland
Location status: Recruiting
Location contact
Aisling Hegarty
CONTACT
Aisling Hegarty
CONTACT
NCT Number: NCT07443579
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Beaumont, Dublin, D09V2N0, Ireland
Location status: Recruiting
Aisling Hegarty
CONTACT
Aisling Hegarty
CONTACT
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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.
Time frame: Immediately before and immediately after mammography (same study visit)
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 after mammography (same study visit)
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: Following image acquisition (retrospective review after mammography during normal reporting timeframe institutionally)
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: During mammography (same study visit)
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)
Compressed breast thickness will be recorded in millimetres from the mammography system and compared across sequencing groups.
Time frame: During mammography (same study visit)
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)
Total time taken to complete mammography will be recorded in minutes and compared across sequencing groups.
Contact information is provided by the study sponsor or research team.
Royal College of Surgeons, Ireland
Other
Acronym: MammoView
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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