Retrospective Evaluation of Ultrasound-assisted Tumor Surgery in Breast-conserving Therapy (MAC004)

April 2, 2026 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

273

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Department for Women's Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent breast-conserving mammosurgery using the standardized ultrasound ruler technique from 2020 to 2023, regardless of tumor biology, microcalcifications, focality, or primary chemotherapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Uni- or Bilateral Ductal Carcinoma in Situ (DCIS) or Invasive Breast Cancer
This retrospective, single-center study included 313 surgical procedures performed on 304 patients between January 2020 and December 2023. The patients underwent breast-conserving surgery (BCS) for unilateral or bilateral ductal carcinoma in situ (DCIS) or invasive breast cancer. All surgeries were performed by a single surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of surgery
Time Frame: During surgery
During surgery
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.
Day of excision
Number of Shavings
Time Frame: During surgery
Number of shavings was recorded intraoperatively, with each shaving representing additional tissue removed to achieve clear margins.
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SenoEx_MAC004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe