Study Results
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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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2016-12-12
2019-12-12
Brief Summary
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Detailed Description
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To increase the echogenicity of the blood in the ultrasound, microbubbles were developed working as stable, biocompatible contrast agent in ultrasound. Such a clinically approved ultrasound contrast agent is SonoVue® (Bracco International B.V., Amsterdam). SonoVue® is approved by the European Medicines Agency (EMA) (approval number EU/1/01/177/002) for the visualization of focal vascularization lesions of the liver and breast within Doppler sonography and is applied in breast cancer patients primarily for the purpose of diagnosis as well as to evaluate the response to the neoadjuvant used chemotherapy.
Animal studies using the contrast enhanced ultrasound have shown that the administration of this contrast agent increases the penetration and accumulation of drugs in the tumor as well as the permeability of the blood-brain barrier resulting in a precise and effective drug distribution. In the tumor animal model it could be shown that a combined treatment with chemotherapy and contrast enhanced ultrasound results in a decreased tumor growth and a prolonged survival. Patients with inoperable pancreatic cancer showed a reduced tumor growth and better tolerability of chemotherapy when administrating the contrast enhanced diagnostic ultrasound during palliative chemotherapy. This could be due to the better tumor response, but also due to the more targeted chemotherapy distribution.
The purpose of this study is to examine whether the use of the contrast enhanced diagnostic ultrasound during neoadjuvant chemotherapy results in an increased tumor regression in comparison to native ultrasound. It is an Investigator Initiated Trial and is funded by internal means.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound
SonoVue
As part of the study therapy supportive ultrasound will be performed with iv Infusion of the chemotherapeutic agent.
B
Application and measurement of tumor size using contrast agent-enhanced diagnostic ultrasound
No interventions assigned to this group
Interventions
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SonoVue
As part of the study therapy supportive ultrasound will be performed with iv Infusion of the chemotherapeutic agent.
Eligibility Criteria
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Inclusion Criteria
* age \> 18 yrs
* histologically confirmed primary breast cancer including all intrinsic subtypes
* treatment with neoadjuvant chemotherapy
* persons who are legally competent and mentally able to follow the instructions of the study team
Exclusion Criteria
* right-left shunt,
* severe pulmonary hypertension (pulmonary arterial pressure \> 90 mmHg)
* uncontrolled systemic hypertension
* acute respiratory distress syndrome
* pregnancy
* commitment of the patient to any resident institution by order of any court or authority
* expectation of missing compliance
* alcohol or drug abuse
* patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
18 Years
ALL
Yes
Sponsors
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Univ.-Prof. Dr. med. F. Kiessling
UNKNOWN
RWTH Aachen University
OTHER
Responsible Party
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Elmar Stickeler
Univ.-Prof. Dr. med.
Principal Investigators
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Elmar Stickeler, niv.-Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Gynecology and Obstetrics
Locations
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Department of Gynecology and Obstetrics
Aachen, , Germany
Countries
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Central Contacts
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Elmar Stickeler, Univ.-Prof. Dr. med.
Role: CONTACT
Phone: +49 241 80 88400
Email: [email protected]
Fabian Kiessling, Univ.-Prof. Dr. med.
Role: CONTACT
Phone: +49 241 80 80116
Email: [email protected]
Facility Contacts
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Elmar Stickeler, Univ.-Prof. Dr. med.
Role: primary
Other Identifiers
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16-134
Identifier Type: -
Identifier Source: org_study_id