NCT03737266

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

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

October 1, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

4.3 years

First QC Date

October 16, 2018

Last Update Submit

February 13, 2024

Conditions

Breast Cancer Surgery

Outcome Measures

Primary Outcomes (1)

  • R0 resection rate

    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

    3 years

Secondary Outcomes (2)

  • Weight of primary resedate

    3 years

  • Time for cut and sew

    During surgery

Study Arms (2)

Sonographically assisted breast surgery

EXPERIMENTAL

Sonography assisted breast surgery

Procedure: Sonographically assisted breast surgeryProcedure: Conventional breast surgery

Conventional breast surgery

ACTIVE COMPARATOR

Conventional breast surgery

Procedure: Sonographically assisted breast surgeryProcedure: Conventional breast surgery

Interventions

Sonographically assisted breast surgeryPROCEDURE

Sonography

Conventional breast surgerySonographically assisted breast surgery
Conventional breast surgeryPROCEDURE

Conventional

Conventional breast surgerySonographically assisted breast surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Sonographically not clearly delineate resection areal
  • Simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Women's Health

Tübingen, Baden-Wurttemberg, 72086, Germany

Location

Study Officials

  • Markus Hahn, Prof. Dr.

    Department of Women's Health, University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 16, 2018

First Posted

November 9, 2018

Study Start

October 1, 2018

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations

DE(1)