NCT03385200 is a Phase 3 clinical trial of SonoVue in Early Primary Breast Cancer, sponsored by RWTH Aachen University.

Who is sponsoring NCT03385200?

NCT03385200 is sponsored by RWTH Aachen University.

What drugs are being tested in NCT03385200?

Interventions in NCT03385200: SonoVue.

What condition does NCT03385200 study?

NCT03385200 studies Early Primary Breast Cancer.

Is NCT03385200 still recruiting?

NCT03385200 is currently status unknown. Last updated 28 December 2017.

Last reviewed 2017-12-28 · How we verify

NCT03385200

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

KVUS at Neoadjuvant CTx of Breast Cancer

Status unknown Phase 3 Last updated 28 December 2017

What this trial tests

Phase 3 trial testing SonoVue in Early Primary Breast Cancer in 60 participants. Status unknown.

Timeline

12 December 2016

Primary endpoint
12 June 2019

12 December 2019

Quick facts

Lead sponsor	RWTH Aachen University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	12 December 2016
Primary completion	12 June 2019
Estimated completion	12 December 2019
Sites	1 location across Germany

Drugs / interventions tested

SonoVue

Conditions studied

Early Primary Breast Cancer — all drugs for Early Primary Breast Cancer →

Sponsor

RWTH Aachen University

Who can join

18 and older, any sex, with Early Primary Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Ultrasound-Responsive Cavitation Nuclei for Therapy and Drug Delivery.
Kooiman K, Roovers S, Langeveld SAG, Kleven RT, et al · · 2020 · cited 212× · PMID 32165014 · DOI 10.1016/j.ultrasmedbio.2020.01.002
Motion model ultrasound localization microscopy for preclinical and clinical multiparametric tumor characterization.
Opacic T, Dencks S, Theek B, Piepenbrock M, et al · · 2018 · cited 181× · PMID 29670096 · DOI 10.1038/s41467-018-03973-8
Applications of Ultrasound-Mediated Drug Delivery and Gene Therapy.
Sitta J, Howard CM. · · 2021 · cited 35× · PMID 34768922 · DOI 10.3390/ijms222111491
Effects of contrast-enhanced ultrasound treatment on neoadjuvant chemotherapy in breast cancer.
Rix A, Piepenbrock M, Flege B, von Stillfried S, et al · · 2021 · cited 32× · PMID 34646386 · DOI 10.7150/thno.64767
Modulating cancer mechanopathology to restore vascular function and enhance immunotherapy.
Mpekris F, Panagi M, Charalambous A, Voutouri C, et al · · 2024 · cited 28× · PMID 38944037 · DOI 10.1016/j.xcrm.2024.101626
Ultrasound-Mediated Drug Delivery With a Clinical Ultrasound System: <i>In Vitro</i> Evaluation.
de Maar JS, Rousou C, van Elburg B, Vos HJ, et al · · 2021 · cited 19× · PMID 34737709 · DOI 10.3389/fphar.2021.768436
A synergistic approach for modulating the tumor microenvironment to enhance nano-immunotherapy in sarcomas.
Mpekris F, Panagi M, Charalambous A, Voutouri C, et al · · 2024 · cited 13× · PMID 38520790 · DOI 10.1016/j.neo.2024.100990
The synergistic potential of mechanotherapy and sonopermeation to enhance cancer treatment effectiveness.
Neophytou C, Stylianopoulos T, Mpekris F. · · 2025 · cited 6× · PMID 40337117 · DOI 10.1038/s44341-025-00017-3

Verify or expand the search:

Other trials of SonoVue

Trials testing the same drug.

NCT07365709 — Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension · NA · not yet recruiting
NCT06497959 — Study of Placental Vascularization Using Contrast Ultrasound · Phase 3 · recruiting
NCT04920214 — Application Value of CEUS Li-RADS in Hepatic Focal Lesions in Patients With Non-high Risk Factors for HCC · unknown
NCT04146441 — Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma · Phase 2 · completed
NCT03477019 — Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer · Phase 1, PHASE2 · completed

Other RWTH Aachen University trials

Trials by the same sponsor.

NCT06390384 — Prevention Programme for Improvement of Well-being and Level of Participation in Adolescents With Enhanced Psychiatric B · NA · not yet recruiting
NCT07322796 — Smoking Cessation Before Bronchoscopy or CT-guided Puncture · recruiting
NCT04996914 — Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma · NA · not yet recruiting
NCT07053956 — Impact of Chewing Gum on FeNO Levels in Patients With Bronchial Asthma · NA · completed
NCT07140536 — The Impact of Treadmills and Cooler Environments for Office Workplaces on Ergonomics, Heating Energy Requirements, Perfo · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03385200 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by RWTH Aachen University
Last refreshed: 28 December 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03385200.

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