Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Cholangiocarcinoma

Liver Cirrhosis

Carcinoma, Hepatocellular

Liver Diseases

Liver Neoplasms

Fibrosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Bile Duct Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients with any of the following conditions:

liver cirrhosis of any origin chronic hepatitis B infection chronic hepatitis C infection with advanced fibrosis non-alcoholic steatohepatitis (NASH) hemochromatosis

Interventions: B-mode ultrasound, contrast enhanced ultrasound (CEUS); MRI / histology

CEUS with SonoVue following standardized protocol

contrast enhanced ultrasound (CEUS)

Histology

Barbara Schellhaas, MD

Deike Strobel, MD

Aim of this prospective national multicenter study is to improve standardization of contrast-enhanced ultrasound (CEUS) in the non-invasive diagnosis of hepatocellular carcinoma (HCC) in high-risk patients.

The study is funded by the German Society for Ultrasound in Medicine (DEGUM).

To date, CEUS criteria for non-invasive diagnosis of HCC include arterial phase hyperenhancement, followed by contrast washout in the portal venous or late phase. We would like to investigate the following points:

1. whether arterial hyperenhancement alone is sufficient for the definite diagnosis of HCC in cirrhosis with CEUS
2. whether a further clearly-defined point of assessment in the late phase after 4-6 minutes is of additional diagnostic value in focal liver lesions showing no contrast washout after 3 minutes
3. diagnostic value of CEUS-based standardised diagnostic algorithms (ESCULAP = Erlanger Synopsis of Contrast Enhanced Ultrasound for Liver lesion Assessment in Patients at risk; CEUS LI-RADS = Contrast Enhanced Ultrasound Liver Imaging Reporting and Data System) for non-invasive diagnosis of HCC in high-risk patients (diagnostic accuracy, interobserver-variability, feasability in clinical Routine).

Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study

Standardized Contrast-enhanced Ultrasound (CEUS) -Algorithms for the Non-invasive Diagnosis of Hepatocellular Carcinoma (HCC) in High-risk-patients - a Prospective German Multicenter Study

Diagnostic accuracy, interobserver-variabilty and feasability in clinical routine for CEUS-based algorithms Reference Standard: histology / MRI

Sensitvity, specificity, positive and negative predictive value of arterial hyperenhancement only compared with arterial hyperenhancement followed by contrast washout for non-invasive diagnosis of HCC in high-risk patients Reference Standard: histology / MRI

Diagnostic value of an additional standardised examination point in the late phase after 4-6 minutes in lesions without contrast washout after 3 minutes Reference Standard: histology / MRI

Sensitvity, specificity, positive and negative predictive value of contrast-enhanced ultrasound for non-invasive diagnosis of ICC in high-risk patients / differential diagnosis of HCC versus ICC Reference Standard: histology

ESCULAP versus CEUS LI-RADS (diagnostic accuracy, interobserver agreement) Reference Standard: histology / MRI

Comparison of CEUS and MRI for non-invasive diagnosis of HCC (diagnostic accuracy, interobserver agreement) Reference Standard: histology

correlation of histological grading and contrast enhancement pattern

University Hospital Erlangen

Neoplasm Metastasis

Hyperplasia

Hemangioma

Focal Nodular Hyperplasia

Nodular Regenerative Hyperplasia

The group will comprise any patients with an unknown liver mass at the time of diagnostic imaging.

Stephanie R Wilson, MD

This comparison study is performed to show equivalence of CEUS with CECT or CEMR to diagnose noninvasively focal liver masses. This is a multi-center prospective cohort study of 250 subjects, which will be performed at four institutions in Canada. Subjects with a focal liver mass, measuring at least 2.5 centimeters in maximal diameter, will undergo a conventional baseline sonogram followed by a contrast enhanced ultrasound (CEUS). CEUS will be performed on standard ultrasound scanners with contrast specific imaging capability. The contrast agent used is Definity (Lantheus Medical Imaging, Billerica,MA) All subjects will have either a dedicated hepatic contrast enhanced CT or MR scan within 60 days of the CEUS as per the standard of care in the institution. Anonymized image files from all imaging will be shown independently to two readers, blinded to all clinical and demographic data, who will predict malignancy and diagnosis.

Contrast Enhanced (CE) Ultrasound and CE Computed Tomography or CE Magnetic Resonance Imaging in Liver Masses

Characterization of Liver Masses With Contrast Enhanced Ultrasound (CEUS): A Comparison With Standard Institutional Contrast Enhanced CT (CECT) or MR Scan (CEMRI)

Vancouver General Hospital

London Health Sciences Centre

Centre hospitalier de l'Université de Montréal (CHUM)

Foothills Medical Centre

Clinical Professor University of Calgary

Urinary Tract, Sexual Organs, and Pregnancy 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

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Vasodilator Agents

Respiratory System Agents

Nitric Oxide

RRx-001

Jeffrey Infante, MD

Tony Reid, MD

The purpose of this study is to evaluate the safety and pharmacokinetic profile of RRx-001 for injection in subjects with advanced solid tumors or lymphomas for which there are no currently accepted curative therapies. This study will also conduct an exploratory evaluation of objective tumor response using CT or MRI.

The DINAMIC (DINitroazetidines As Medications In Cancer) trial represents a provascular approach to temporarily change tumor blood flow and oxygenation. Blood supply to most tumors is poor, causing parts of tumors to have a low oxygen content which promotes aggressiveness and metastasis. The DINAMIC trial uses specific imaging techniques (including ultrasound), biopsy, and breath analysis to provide an early assessment of therapeutic activity.

Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects

A Phase I, Open-Label, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of RRx-001 in Subjects With Advanced Solid Tumors or Lymphomas For Which There Are No Currently Accepted Curative Therapies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Standardized CEUS Algorithms for Diagnosis of HCC - Prospective German Multicenter Study	NCT03405909	Hepatocellular ... Cholangiocarcin... Liver Cirrhosis Liver Cancer Liver Neoplasms Liver Diseases	contrast enhanc... MRI Histology	18 Years -	University Hospital Erlangen
Contrast Enhanced (CE) Ultrasound and CE Computed Tomography or CE Magnetic Resonance Imaging in Liver Masses	NCT00828607	Liver Tumors		18 Years - 90 Years	Foothills Medical Centre
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)
Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects	NCT01359982	Malignant Solid... Lymphomas	RRx-001 RRx-001 RRx-001 RRx-001 RRx-001 RRx-001	18 Years -	EpicentRx, Inc.

Spots Global Cancer Trial Database for contrast enhanced ultrasound (ceus)