Best order of mammogram views after breast-conserving surgery
Optimal Mammography View Sequencing in Women With a History of Breast Cancer Undergoing Surveillance Mammography
This test sees if the order in which mammogram views are taken affects pain and satisfaction for women who had breast-conserving surgery within the past five years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 1 site (Beaumont, Dublin) |
| Trial ID | NCT07443579 on ClinicalTrials.gov |
What this trial studies
This single-centre, randomized, parallel-group trial assigns 400 women 1:1:1:1 to one of four mammography view sequences during their first annual surveillance mammogram after breast-conserving surgery and radiotherapy. Pain is measured with a visual analogue scale before and after the exam and patient satisfaction is recorded with a post-procedure questionnaire as the primary outcomes. Secondary outcomes include blinded retrospective image quality scoring using PGMI by two radiologists, recorded compression force, and breast thickness. The study uses an intention-to-treat analysis and is conducted at the Beaumont RCSI Cancer Centre over approximately 2.5 years.
Who should consider this trial
Good fit: Women aged 18 or older who had breast-conserving surgery (wide local excision) and radiotherapy within the past five years and are attending their first annual surveillance mammogram after treatment are ideal candidates.
Not a fit: Patients with a prior mastectomy, bilateral wide local excision, men, those more than five years post-treatment, or those unable to give informed consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, changing the order of views could reduce discomfort during mammography and improve patient satisfaction while maintaining image quality.
How similar studies have performed: There is limited prior research on view sequencing and its effects on pain or image quality, so this approach is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beaumont, Dublin
- Beaumont RCSI Cancer Centre — Beaumont, Dublin, Ireland (Recruiting)
Study contacts
- Study coordinator: Prof Nuala Healy
- Email: nualahealy@rcsi.ie
- Phone: +35318093000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.