Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy

NCT ID: NCT03737266

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2023-01-01

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sonographically assisted breast surgery

Sonography assisted breast surgery

Group Type EXPERIMENTAL

Sonographically assisted breast surgery

Intervention Type PROCEDURE

Sonography

Conventional breast surgery

Intervention Type PROCEDURE

Conventional

Conventional breast surgery

Conventional breast surgery

Group Type ACTIVE_COMPARATOR

Sonographically assisted breast surgery

Intervention Type PROCEDURE

Sonography

Conventional breast surgery

Intervention Type PROCEDURE

Conventional

Interventions

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Sonographically assisted breast surgery

Sonography

Intervention Type PROCEDURE

Conventional breast surgery

Conventional

Intervention Type PROCEDURE

Eligibility Criteria

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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
* Simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Markus Hahn, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Women's Health, University Hospital Tuebingen

Locations

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Department for Women's Health

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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Seno_Ex_MAC 003

Identifier Type: -

Identifier Source: org_study_id

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