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Conserving Breast Surgery - Comparison of Conventional With Sonography (MAC-001)

This study has been completed.
Information provided by (Responsible Party):
University Women's Hospital Tübingen Identifier:
First received: August 20, 2014
Last updated: April 12, 2017
Last verified: August 2014
Aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse

Condition Intervention
Breast Surgery
Procedure: Sonography assisted breast surgery
Procedure: Conventional breast surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
Official Title: Comparison of Sonographically Assisted With Conventionally Breast Surgery - Prospective, Randomised, Multicenter, Parallel Group Study With Two Study Arms

Further study details as provided by University Women's Hospital Tübingen:

Primary Outcome Measures:
  • Rate of second tumor resections [ Time Frame: Five years ]

Enrollment: 46
Study Start Date: April 2009
Study Completion Date: May 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sonographically assisted breast surgery
Sonographically assisted breast surgery
Procedure: Sonography assisted breast surgery
Active Comparator: Conventional breast surgery
Conventional breast surgery
Procedure: Conventional breast surgery


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 to 70 years
  • Female
  • Presurgical validated breast cancer

Exclusion Criteria:

  • Sonographically not defined report
  • Lobular breast cancer
  • Extensive ductal carcinoma in situ
  Contacts and Locations
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Please refer to this study by its identifier: NCT02222675

University Women's Hospital
Tübingen, Germany, 72076
Sponsors and Collaborators
University Women's Hospital Tübingen
  More Information

Responsible Party: University Women's Hospital Tübingen Identifier: NCT02222675     History of Changes
Other Study ID Numbers: MAC-001_1.1
Study First Received: August 20, 2014
Last Updated: April 12, 2017 processed this record on May 25, 2017