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

Arm | Intervention/treatment |
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Active Comparator: A
Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound
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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
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- Tumor size reduction (1) [ Time Frame: 18 / 24 weeks ]pCR (pathohistological complete remission)
- Tumor size reduction (2) [ Time Frame: 18 / 24 weeks ]cCR (clinical complete remission)
- Tumor size reduction (3) [ Time Frame: 18 / 24 weeks ]measured by ultrasound (% reduction in therapy)
- proliferation rate of the tumor cells [ Time Frame: 18 / 24 weeks ]Ki67 protein analysis
- narrowing the invasion front of the tumors [ Time Frame: 18 / 24 weeks ]ultrasound
- macrophage density in the tumor [ Time Frame: 18 / 24 weeks ]serum chemistry
- vascularization of the tumor [ Time Frame: 18 / 24 weeks ]ultrasound
- tolerability of chemotherapy [ Time Frame: 18 / 24 weeks ]% reduction in therapy

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
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 |
Germany | |
Department of Gynecology and Obstetrics | Recruiting |
Aachen, Germany | |
Contact: Elmar Stickeler, Univ.-Prof. Dr. med. +49 241 80 88400 estickeler@ukaachen.de |
Principal Investigator: | Elmar Stickeler, niv.-Prof. Dr. med. | Department of Gynecology and Obstetrics |
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. |
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 |
breast cancer, neoadjuvant chemotherapy, ultrasound, microbubbles |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |