Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy

Breast Cancer Surgery Clinical Trial

Official title:

Sonographically Assisted Versus Conventionally Breast Surgery in Breast Cancer Patients With an Indication for Breast Conserving Surgery After Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737266
• Other study ID #: Seno_Ex_MAC 003
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2024
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breast Cancer Surgery
• Breast Neoplasms

Intervention

Procedure:
• Sonographically assisted breast surgery
Sonography
• Conventional breast surgery
Conventional

Locations

Country	Name	City	State
Germany	Department for Women's Health	Tübingen	BW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight of primary resedate	weight of the tumor tissue removed during surgery for cancer	3 years
Secondary	Time for cut and sew	duration of the surgical procedure from the initial incision to the completion of the closure of the incision site	During surgery