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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by University Women's Hospital Tübingen.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
University Women's Hospital Tübingen Identifier:
First received: August 20, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
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: Open Label
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 ]

Estimated Enrollment: 142
Study Start Date: April 2009
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sonographically assisted breast surgery Procedure: Sonography assisted breast surgery
Active Comparator: 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

Contact: Markus Hahn, MD

University Women's Hospital Recruiting
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: August 20, 2014 processed this record on March 23, 2017