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Completed

NCT Number: NCT07519668

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Department for Women's Health

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Exclusion criteria for BCT
  • Status after neoadjuvant chemotherapy

Treatment and study plan

Primary outcomes

  1. R1 resection rates

    Time frame: 3 years

    In this retrospective study, R1 resections were defined as cases requiring a follow-up surgery due to incomplete tumor removal.

Secondary outcomes

  1. Weight of main specimen

    Time frame: Day of excision

    The weight of the main specimen was recorded immediately after excision at the time of surgical removal.

  2. Duration of surgery

    Time frame: During surgery

  3. Number of Shavings

    Time frame: During surgery

    Number of shavings was recorded intraoperatively, with each shaving representing additional tissue removed to achieve clear margins.

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Acronym: MAC004

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

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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