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KVUS at Neoadjuvant CTx of Breast Cancer

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ClinicalTrials.gov Identifier: NCT03385200
Recruitment Status : Unknown
Verified December 2017 by Elmar Stickeler, RWTH Aachen University.
Recruitment status was:  Recruiting
First Posted : December 28, 2017
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Univ.-Prof. Dr. med. F. Kiessling
Information provided by (Responsible Party):
Elmar Stickeler, RWTH Aachen University

Study Description
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Brief Summary:
Effect of the contrast-enhanced diagnostic ultrasound during neoadjuvant chemotherapy of breast cancer on the achieved tumor size reduction and tolerability of chemotherapy

Condition or disease Intervention/treatment Phase
Early Primary Breast Cancer Drug: SonoVue Phase 3

Detailed Description:

The 5-year survival rate of breast cancer patients is decreasing in the advanced, metastatic stage from 99% to 26%. Therefore an optimization of the therapy of advanced breast cancer is urgently needed.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parellel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contrast-enhanced Ultrasound in Neoadjuvant Chemotherapy of Breast Cancer
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : June 12, 2019
Estimated Study Completion Date : December 12, 2019

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound
 Drug: SonoVue
As part of the study therapy supportive ultrasound will be performed with iv Infusion of the chemotherapeutic agent.
No Intervention: B
Application and measurement of tumor size using contrast agent-enhanced diagnostic ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. Tumor size reduction (1) [ Time Frame: 18 / 24 weeks ]
    pCR (pathohistological complete remission)

  2. Tumor size reduction (2) [ Time Frame: 18 / 24 weeks ]
    cCR (clinical complete remission)

  3. Tumor size reduction (3) [ Time Frame: 18 / 24 weeks ]
    measured by ultrasound (% reduction in therapy)


Secondary Outcome Measures :
  1. proliferation rate of the tumor cells [ Time Frame: 18 / 24 weeks ]
    Ki67 protein analysis

  2. narrowing the invasion front of the tumors [ Time Frame: 18 / 24 weeks ]
    ultrasound

  3. macrophage density in the tumor [ Time Frame: 18 / 24 weeks ]
    serum chemistry

  4. vascularization of the tumor [ Time Frame: 18 / 24 weeks ]
    ultrasound

  5. tolerability of chemotherapy [ Time Frame: 18 / 24 weeks ]
    % reduction in therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • written informed consent
  • 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:

  • hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385200


Contacts
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Contact: Elmar Stickeler, Univ.-Prof. Dr. med. +49 241 80 88400 estickeler@ukaachen.de
Contact: Fabian Kiessling, Univ.-Prof. Dr. med. +49 241 80 80116 fkiessling@ukaachen.de

Locations
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Germany
Department of Gynecology and Obstetrics Recruiting
Aachen, Germany
Contact: Elmar Stickeler, Univ.-Prof. Dr. med.    +49 241 80 88400    estickeler@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Univ.-Prof. Dr. med. F. Kiessling
Investigators
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Principal Investigator: Elmar Stickeler, niv.-Prof. Dr. med. Department of Gynecology and Obstetrics
More Information
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Responsible Party: Elmar Stickeler, Univ.-Prof. Dr. med., RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03385200    
Other Study ID Numbers: 16-134
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The study results will be published in at least one scientific article.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elmar Stickeler, RWTH Aachen University:
breast cancer, neoadjuvant chemotherapy, ultrasound, microbubbles
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases