Skip to main content
OpenTrials
Completed

NCT Number: NCT03737266

Comparison of Conventional With Sonography Assisted Breast 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Surgery

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department for Women's Health

Tübingen, Baden-Wurttemberg, 72086, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sonographically assisted breast surgery

Procedure

Sonography

Conventional breast surgery

Procedure

Conventional

Primary outcomes

  1. 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

Secondary outcomes

  1. Weight of primary resedate

    Time frame: 3 years

    weight of the tumor tissue removed during surgery for cancer

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2018
Registry last updated
Feb 14, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.