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A new method of estimating the volume of breast tissue removed following breast-conserving surgery using its weight and x-ray appearance

Development of a new approach to measure the volume of breast tissue removed during wide local excision using specimen weight and mammographic density

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15283352
Enrollment
356
Registered
2023-06-14
Start date
2023-10-11
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with breast cancer undergoing breast-conserving surgery Cancer

Interventions

This is a proof-of-concept diagnostic study which evaluates a novel method of obtaining an estimate of the breast volume excised with a WLE by correlating specimen weight and radiological density adju

Sponsors

University Hospitals of Derby and Burton NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women with a breast cancer diagnosis (both invasive and in-situ) undergoing breast-conserving surgery with or without oncoplastic techniques

Exclusion criteria

Exclusion criteria: Excision of skin and/or nipple-areola complex required

Design outcomes

Primary

MeasureTime frame
Comparison between surgical specimen volume estimate obtained with the new regression-based model and actual specimen volume obtained using the gold standard measurement (Archimedes/water displacement method) at the time of surgery measured with Bland-Altman analysis

Secondary

MeasureTime frame
Accuracy of the volume estimate obtained with the regression-based model in comparison with the current estimate method using paired t-tests and the Intraclass-Correlation-Coefficient at the time of surgery

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026