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
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parellel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: A
Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound
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
- 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
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 firstname.lastname@example.org|
|Contact: Fabian Kiessling, Univ.-Prof. Dr. med.||+49 241 80 email@example.com|
|Department of Gynecology and Obstetrics||Recruiting|
|Contact: Elmar Stickeler, Univ.-Prof. Dr. med. +49 241 80 88400 firstname.lastname@example.org|
|Principal Investigator:||Elmar Stickeler, niv.-Prof. Dr. med.||Department of Gynecology and Obstetrics|