KVUS at Neoadjuvant CTx of Breast Cancer

RWTH Aachen University

Status and phase

Unknown

Phase 3

Conditions

Early Primary Breast Cancer

Treatments

Drug: SonoVue

Study type

Interventional

Funder types

Other

Identifiers

NCT03385200

16-134

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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