NCT02222675

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

6 years

First QC Date

August 20, 2014

Last Update Submit

July 19, 2024

Conditions

Breast Surgery

Outcome Measures

Primary Outcomes (1)

  • Rate of second tumor resections

    Five years

Study Arms (2)

Sonographically assisted breast surgery

EXPERIMENTAL

Sonographically assisted breast surgery

Procedure: Sonography assisted breast surgery

Conventional breast surgery

ACTIVE COMPARATOR

Conventional breast surgery

Procedure: Conventional breast surgery

Interventions

Sonography assisted breast surgeryPROCEDURE
Sonographically assisted breast surgery
Conventional breast surgeryPROCEDURE
Conventional breast surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 years
  • Female
  • Presurgical validated breast cancer

You may not qualify if:

  • Sonographically not defined report
  • Lobular breast cancer
  • Extensive ductal carcinoma in situ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Women's Hospital

Tübingen, 72076, Germany

Location

Related Publications (1)

  • Hoffmann J, Marx M, Hengstmann A, Seeger H, Oberlechner E, Helms G, Rohm C, Ott C, Wallwiener D, Stabler A, Wiesinger B, Hartkopf AD, Brucker SY, Hahn M. Ultrasound-Assisted Tumor Surgery in Breast Cancer - A Prospective, Randomized, Single-Center Study (MAC 001). Ultraschall Med. 2019 Jun;40(3):326-332. doi: 10.1055/a-0637-1725. Epub 2018 Jul 5.

    PMID: 29975969DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 21, 2014

Study Start

April 1, 2009

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

July 22, 2024

Record last verified: 2024-07

Locations

DE(1)