Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy

February 13, 2024 updated by: University Hospital Tuebingen

Sonographically Assisted Versus Conventionally Breast Surgery in Breast Cancer Patients With an Indication for Breast Conserving Surgery After Neoadjuvant Chemotherapy

Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of R1 resection compared to the procedure without sonographic visualisation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Germany
    • BW
      • Tübingen, BW, Germany, 72086
        • 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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 80 years
  • Female
  • Presurgical validated breast cancer
  • Unifocal to multifocal findings
  • Palpable and/o non-palpable findings
  • Neoadjuvant chemotherapy
  • Indication for breast conserving therapy
  • General operation ability and anesthesia ability
  • Consent to conventional breast conserving breast surgery with wire marking
  • Ability and will to follow the study conditions
  • Written declaration of consent after clarification

Exclusion Criteria:

  • Sonographically not clearly delineate resection areal
  • Exclusion criteria for breast conserving therapy
  • Simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sonographically assisted breast surgery
Sonography assisted breast surgery
Procedure: Sonographically assisted breast surgery
Sonography
Procedure: Conventional breast surgery
Conventional
Active Comparator: Conventional breast surgery
Procedure: Sonographically assisted breast surgery
Sonography
Procedure: Conventional breast surgery
Conventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: 3 years
proportion of surgical procedures for cancer in which the surgeon is able to completely remove all detectable tumor tissue with negative margins, indicating that no cancer cells remain in the surgical site
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight of primary resedate
Time Frame: 3 years
weight of the tumor tissue removed during surgery for cancer
3 years
Time for cut and sew
Time Frame: During surgery
duration of the surgical procedure from the initial incision to the completion of the closure of the incision site
During surgery

Collaborators and Investigators

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

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Markus Hahn, Prof. Dr., Department of Women's Health, 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)

October 1, 2018

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Seno_Ex_MAC 003

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 Surgery

Clinical Trials on Sonographically assisted breast surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe