Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

2.4 ml Bolus Injection by intravenous canule. Multi-repeatable (up to 4 bolus) if necessary.

SonoVue

H. Wijkstra, Prof. Dr. Ir.

With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. CEUS image interpretation is difficult and requires a well-trained expert. To overcome these difficulties CEUS quantification techniques can be of use. The techniques used in this protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e) and BRACCO, Geneva.

The investigators hypothesize improvement of the PCa detection rate with quantification, compared with subjective CEUS interpretation and known numbers in literature.

Also a comparison between quantification results and tumour differentiation grade (Gleason score) will be made, the investigators hypothesize a positive correlation.

Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer

Prostate cancer detection rate by quantification.

Answering the question: What is the difference in, for malignancy suspicious, areas between CEUS quantification and subjective interpretation in relation to the histological biopsy results?

Prostate cancer Gleason score compared to quantification results

Answering the question: Is there a relation between Gleason score and quantification results?

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Principal Investigator

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Neoplasm Metastasis

Liver Diseases

Hyperplasia

Hemangioma

Focal Nodular Hyperplasia

Neoplastic Processes

Gastrointestinal Diseases

Nodular Regenerative Hyperplasia

Hematinics

All Drugs and Chemicals

Liver Extracts

Focal liver lesions: patients discovered with new, uncharacteristic focal liver lesions at standard ultrasound

Mihai A Socaciu, MD, PhD student

The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation of de novo focal liver lesions in clinical practice, in a prospective multi-center design.

Focal liver lesions (FLL) are quite frequently discovered in daily practice at routine ultrasound and sometimes require the use of extensive investigations for a correct diagnosis, thus increasing the costs and duration of diagnosis. On the other hand, due to screening strategies for patients with liver cirrhosis, FLL are discovered very early in these patients, and they must be evaluated in order to establish a therapeutic strategy (including transplantation, surgical resection or percutaneous echoguided procedures).

Contrast enhanced ultrasound (CEUS) using second generation contrast agents is a relatively new imaging modality that allows the characterization of FLL and allows a positive diagnosis based on the vascular pattern of the lesion. The advantages of this method are the low cost as compared with other imaging modalities and the fact that it can be performed immediately after standard abdominal ultrasound, so approximately 5 minutes after CEUS (the total duration of this investigation) a confident diagnosis can be obtained.

The place of CEUS in the diagnostic algorithm of FLL is not very well established. The European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) issued the first Guidelines regarding the use of CEUS in 2004, revised in 2008, in which the main indications of this method are presented.

The purpose of this study is to establish the value of CEUS in the evaluation of de novo FLL in clinical practice.

The study will include patients discovered with de novo FLL at standard ultrasound in which the ultrasound study is not conclusive for the positive diagnosis (the patients with simple cysts or known FLL under CEUS follow up will be excluded form the study). The standard ultrasound will be followed by the contrast study using SonoVue® (Bracco, Italy) as contrast agent. The amount of contrast agent will be documented in every patient (it depends on the ultrasound machine used and the suspected diagnosis). The examination will be performed using the dedicated contrast software of each ultrasound machine used in the study. The investigators shall also document in every patient: the indication for CEUS study, a short history including the presence of chronic hepatopathies or malignancies, the ultrasound machine used and the operator. Each examination will last about 5 min after bolus injection and will be documented by 4 video files no longer than 30 seconds each, containing: The standard study, the arterial phase, the portal phase and the late phase. Additional loops can be stored whenever it is considered necessary.

A CEUS diagnosis will be established based on the contrast study. This will be compared with the final diagnosis which will be established based on all available imaging and clinical data: computer tomography, MRI, biopsy, follow up information. A CEUS examination will be considered conclusive if, following contrast, the FLL had a typical enhancement pattern according to the EFSUMB guidelines, and inconclusive if the enhancement pattern of the lesions was not in concordance with this guide.

The stored loops will be also revised by different operators. The study design is prospective, multi-center and will be approved by the ethical review board.

Contrast Enhanced Ultrasound For The Evaluation Of Focal Liver Lesions

Contrast Enhanced Ultrasound for the Evaluation of Focal Liver Lesions - a Multi-center Study on the Usefulness in the Clinical Practice

A CEUS examination will be considered conclusive if, following contrast, the FLL had a typical enhancement pattern according to the EFSUMB guidelines, and inconclusive if the enhancement pattern of the lesions was not in concordance with this guide.

Centrul de Cercetare in Gastroenterologie si Hepatologie, Craiova

Clinica de Gastroenterologie si Hepatologie, UMF Timisoara

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Institutul Clinic Fundeni

Clinica de Gastroenterologie Constanta

Societatea Romana de Ultrasonografie in Medicina si Biologie

Socaciu Mihai

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Application and measurement of tumor size using contrast agent-enhanced diagnostic and therapy supporting (with SonoVue®) ultrasound

Application and measurement of tumor size using contrast agent-enhanced diagnostic ultrasound

As part of the study therapy supportive ultrasound will be performed with iv Infusion of the chemotherapeutic agent.

Elmar Stickeler, Univ.-Prof. Dr. med.

Fabian Kiessling, Univ.-Prof. Dr. med.

Elmar Stickeler, niv.-Prof. Dr. med.

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

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.

KVUS at Neoadjuvant CTx of Breast Cancer

Contrast-enhanced Ultrasound in Neoadjuvant Chemotherapy of Breast Cancer

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

pCR (pathohistological complete remission)

measured by ultrasound (% reduction in therapy)

Univ.-Prof. Dr. med. F. Kiessling

RWTH Aachen University

Univ.-Prof. Dr. med.

One to two bolus (each 2.4mL) of SonoVue per patient in the optimization part

One to four bolus (each 2.4mL) of SonoVue per patient in the main part

Contrast-enhanced ultrasound guided biopsy

Current practice of ultrasound guided systematic biopsy

ultrasound guided systematic biopsy

Maria L Storto, MD

This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.

SonoVue Guided Prostate Biopsy

A Phase III Study to Compare SonoVue Guided Prostate Biopsy With Systematic Biopsy in the Detection of Prostate Malignant Lesions in Patients With Suspected Prostate Cancer

Bracco Imaging S.p.A.

Bracco Diagnostics, Inc

All consenting patients will undergo mpUS imaging prior to surgery with the ultrasound contrast agent Sonovue for the CEUS specific mode.

The ultrasound contrast agent used for the CEUS specific ultrasound mode

H. Wijkstra, Prof dr ir

Rationale: The current limitations in prostate cancer diagnostics, due to lack of accuracy of the available techniques, lead to over- and undertreatment for a significant fraction of patients with prostate cancer. Multiparametric ultrasound (mpUS), a new imaging modality combining different ultrasound parameters, heralds the potential for an accurate imaging-based diagnostic approach accessible to the community at large but formal validation of mpUS against final pathology results are still lacking.

Objective: To validate mpUS as imaging modality for detection and localization of prostate cancer by direct correlation with histopathology of radical prostatectomy specimens

Systematic transrectal ultrasound (TRUS)-guided biopsies in men with a clinical suspicion of prostate cancer, based on digital rectal examination (DRE) and/or prostate-specific antigen (PSA) has been the diagnostic strategy for years. However, this method has known limited sensitivity and risks, as many men without cancer undergo unnecessary biopsies, clinically insignificant cancers are often detected while significant cancers are missed or under-graded and the biopsy procedure itself carries discomfort and morbidity. Prostate imaging capable of identifying clinically significant disease for targeted biopsy with high accuracy and efficiency is thus of importance. mpMRI (multiparametric magnetic resonance imaging) and mpMRI-targeted biopsies are being increasingly used, and they have improved the ability to detect clinically significant cancers, while reducing the diagnosis of insignificant cancers compared to TRUS-guided biopsies. Nevertheless, mpMRI has been limited by inter-reader variability, high level of expertise requirements and heterogeneity in definitions while mpMRI-targeted biopsies alone still misses clinical significant cancers revealed by TRUS-guided biopsies.

There is an ongoing search for new cost-effective, manageable imaging technologies for adequate prostate cancer diagnosis. Various ultrasound modalities are in development striving to increase cancer detection among which contrast-enhanced ultrasound (CEUS) and elastography. Preliminary results of a multiparametric ultrasound (mpUS) approach, combining these different ultrasound modalities, seem promising. The number and quality of studies available, however, is relatively low, emphasizing the need for further work to define the role of mpUS.

This is an investigator-initiated, prospective in-vivo validation study in humans to validate mpUS as imaging modality for detection and localization of prostate cancer by direct correlation with histopathology. Biopsy-proven prostate cancer patients scheduled for radical prostatectomy will be approached and consented to enter this study. Information about the study will be provided both verbally and in written form.

Participants will undergo a mpUS imaging prior to their surgery. For the contrast enhanced mode of the mpUS an additional infusion of an ultrasound contrast agent through an intravenous cannula will be used during transrectal ultrasound scanning for the purpose of the study.

The mpUS imaging data will be evaluated qualitatively and semi-quantitatively using parametric maps by prostate ultrasound experts blinded for radical prostatectomy histopathology. Histopathology will be evaluated qualitatively by an uro-pathologist blinded for mpUS imaging results. Hence, imaging data will be correlated with histopathology in a blinded fashion using a 3D registration system and 3D reconstruction model. Predictive accuracy of mpUS imaging for detection and localization of prostate cancer on histopathology will be analyzed.

At a later stage, a mpUS classifier, most optimally combining the most relevant ultrasound parameters of each modality in one single resulting mpUS parameter will be developed. Furthermore, the additional clinical value of mpUS imaging in prostate cancer diagnostics will be determined by comparing mpUS results with that of available mpMRI data. mpMRI imaging data will be evaluated by an uro-radiologist using the PI-RADS (Prostate Imaging Reporting and Data System) criteria blinded for radical prostatectomy results.

Multiparametric Ultrasound Imaging in Prostate Cancer

Multiparametric Ultrasound (mpUS) as Imaging Modality for the Detection and Localization of Prostate Cancer

Predictive accuracy in terms of sensitivity and specificity of mpUS imaging in the detection and localization of prostate cancer by qualitatively and semi-quantitatively correlation of mpUS imaging to corresponding radical prostatectomy histopathology

Parameters of mpUS (echogenicity, contrast-agent perfusion, contrast-agent dispersion, contrast-agent velocity, tissuedensity) will be assessed

Comparison of predictive accuracy in terms of sensitivity and specificity of mpMRI imaging and mpUS imaging

Amsterdam UMC, location VUmc

prof. dr. Ir. Hessel Wijkstra

Gland and Hormone Related Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Pancreatic Ductal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Carcinoma, Ductal

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

Folfirinox

1,0 ml SonoVue 8ul/ml dispersion is given 9 times at 3,5 minute intervals 9 times, a total dosage of 9 ml. The experimental treatment lasts for 31,5 minutes every treatment day. Administered by authorized site personnel only

FOLFIRINOX Regime according to Norwegian national guidelines

Chemotherapy

Eva Hofsli, md phd

Patients with inoperable pancreatic cancer have extremely poor prognosis with five year survival below 8% in Norway. Life-prolonging chemotherapy has very limited effect, but is the only therapeutic option for these patients. This tumor is characterized by poor uptake and chemoresistance. Toxic effects on healthy tissue restrict doses applied and maintenance of treatment intensity. This severely limits clinical outcome. Increasing the local uptake of chemotherapy has potential benefits for patients in connection to side effects, survival and possible cure. Treatment with Focused Ultrasound (FUS) combined with microbubbles (MBs) is proved promising to improve treatment response in animal and clinical trials. Ultrasound can induce biological effects deep inside the body without surgical intervention. This opens for local delivery of drugs at desired sites. FUS in combination with regular contrast MBs has been reported to influence the delivery of drugs to tumors.

In this trial FUS and MB will be applied to locally advanced pancreatic cancers shortly after the administration of conventional chemotherapy. Primary aim of the trial is to investigate whether the effect of the cytostatic drug, measured in tumor volume, can be increased.

Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma

Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma - A Randomized Controlled Trial

Individual participant data that underlie the results reported in this article, after deidentification(text, tables, figures, and appendices). Interested researchers who provide a reasonable, sound proposal are encouraged to direct this to the first author.

measured by segmented tumor volumes on Computed Tomography of primary PDAC tumor from before treatment (baseline) to after 1 cycle of treatment

Toxicity reported by patients during structured interview after treatment. Type of side effects and severity according to Common Toxicity Criteria (CTC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer	NCT01481441	Prostate Cancer	SonoVue	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contrast Enhanced Ultrasound For The Evaluation Of Focal Liver Lesions	NCT01329458	Focal Nodular H... Toxic Liver Dis... Liver Metastase...		18 Years -	Societatea Romana de Ultrasonografie in Medicina si Biologie
KVUS at Neoadjuvant CTx of Breast Cancer	NCT03385200	Early Primary B...	SonoVue	18 Years -	RWTH Aachen University
SonoVue Guided Prostate Biopsy	NCT00911027	Prostate Cancer	Contrast-enhanc... ultrasound guid...	40 Years -	Bracco Diagnostics, Inc
Contrast Enhanced Ultrasound For The Evaluation Of Focal Liver Lesions	NCT01329458	Focal Nodular H... Toxic Liver Dis... Liver Metastase...		18 Years -	Societatea Romana de Ultrasonografie in Medicina si Biologie
Multiparametric Ultrasound Imaging in Prostate Cancer	NCT03101176	Prostate Cancer Prostatic Neopl...	SonoVue	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma	NCT04146441	Carcinoma, Panc...	SonoVue Chemotherapy	19 Years - 89 Years	St. Olavs Hospital

Spots Global Cancer Trial Database for sonovue

Every month we try and update this database with for sonovue cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sonovue

Every month we try and update this database with for sonovue cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sonovue cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.