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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Women's Hospital Tübingen
Sponsor:
Information provided by (Responsible Party):
University Women's Hospital Tübingen
ClinicalTrials.gov Identifier:
NCT02222675
First received: August 20, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
  Purpose

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of second tumor resections [ Time Frame: Five years ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02222675

Contacts
Contact: Markus Hahn, MD markus.hahn@med.uni-tuebingen.de

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

No publications provided

Responsible Party: University Women's Hospital Tübingen
ClinicalTrials.gov Identifier: NCT02222675     History of Changes
Other Study ID Numbers: MAC-001_1.1
Study First Received: August 20, 2014
Last Updated: August 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on October 01, 2014