KVUS at Neoadjuvant CTx of Breast Cancer | NCT03385200

Studies
KVUS at Neoadjuvant CTx of Breast Cancer

NCT03385200

Sponsor

RWTH Aachen University

Status

Unknown status

Last Update Posted

Dec 28, 2017Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

Early Primary Breast Cancer

Interventions

SonoVue

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2016Actual

Primary Completion Date

Jun 12, 2019Estimated

Completion Date

Dec 12, 2019Estimated

First Submitted Date

Dec 19, 2017

First Submission Date that Met QC Criteria

Dec 27, 2017

First Posted Date

Dec 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 27, 2017

Last Update Posted Date

Dec 28, 2017Actual

Name	Class
Univ.-Prof. Dr. med. F. Kiessling	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound	Drug: SonoVue
B	No Intervention	Application and measurement of tumor size using contrast agent-enhanced diagnostic ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SonoVue	Drug	As part of the study therapy supportive ultrasound will be performed with iv Infusion of the chemotherapeutic agent.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor size reduction (1)	pCR (pathohistological complete remission)	18 / 24 weeks
Tumor size reduction (2)	cCR (clinical complete remission)	18 / 24 weeks
Tumor size reduction (3)	measured by ultrasound (% reduction in therapy)	18 / 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
proliferation rate of the tumor cells	Ki67 protein analysis	18 / 24 weeks
narrowing the invasion front of the tumors	ultrasound	18 / 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elmar Stickeler, Univ.-Prof. Dr. med.	Contact	+49 241 80 88400		estickeler@ukaachen.de
Fabian Kiessling, Univ.-Prof. Dr. med.	Contact	+49 241 80 80116		fkiessling@ukaachen.de

Overall Officials

Name	Affiliation	Role
Elmar Stickeler, niv.-Prof. Dr. med.	Department of Gynecology and Obstetrics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gynecology and Obstetrics	Recruiting	Aachen			Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The study results will be published in at least one scientific article.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided