Retrospective Evaluation of Ultrasound-assisted Tumor Surgery in Breast-conserving Therapy

Retrospective Evaluation of the R1/ Post-resection Rate With Intraoperative Measurement of the Target Volume Using Ultrasound by a Surgeon (Ultrasound-assisted Tumor Surgery) as Part of Breast-conserving Therapy in Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07519668

Acronym

MAC004

Enrollment

273

Registered

2026-04-09

Start date

2020-01-01

Completion date

2023-12-31

Last updated

2026-04-09

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

Conditions

Breast Cancer

Keywords

Breast-Conserving Surgery, Intraoperative ultrasound

Brief summary

The aim of this study is to evaluate whether standardizing intraoperative ultrasound (IOUS) with the "Tübingen Ultrasound Ruler" reduces R1 resection rates in breast-conserving surgery.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age at least 18 years and no more than 80 years (inclusive) * Preoperatively histologically confirmed breast cancer, detectable by ultrasound * Unifocal to multifocal findings * Palpable and/or non-palpable findings * Indication for breast-conserving therapy (BCT)

Exclusion criteria

* Sonographically ambiguous findings * Multicentricity *

Design outcomes

Primary

Measure	Time frame	Description
R1 resection rates	3 years	In this retrospective study, R1 resections were defined as cases requiring a follow-up surgery due to incomplete tumor removal.

Secondary

Measure	Time frame	Description
Weight of main specimen	Day of excision	The weight of the main specimen was recorded immediately after excision at the time of surgical removal.
Duration of surgery	During surgery	—
Number of Shavings	During surgery	Number of shavings was recorded intraoperatively, with each shaving representing additional tissue removed to achieve clear margins.

Countries

Germany

Outcome results