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

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Study participants must be older than 18 years of age who are having an endoscopy performed to evaluate symptoms of GERD such as heartburn, acid taste in the mouth, dysphagia, dyspepsia, or those who are having a screening/surveillance exam for BE.

Glenn M Eisen, MD, MPH

Barrett's esophagus (BE) is a condition that often occurs in patients who have had GERD for a long time. The researchers are interested in BE because it can sometimes become a cancer in the esophagus. The way that we currently diagnose BE is by performing an upper endoscopy and looking for a change in the color of the esophagus. This color change may represent BE. If the doctor sees this, he/she may take biopsies of this area.

Studies have shown that making the diagnosis of BE can be hard to make. One of the reasons why this may be is because doctors may interpret what they see differently during the procedure. In other words, they may see an esophagus that appears normal in color or abnormal in color.

The purpose of this study is to compare two doctors' impressions of the appearance of the esophagus during a single endoscopy procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
Study of Endoscopic Barrett's Esophagus Diagnosis	NCT00591461	Barrett's Esoph... GERD		18 Years - 80 Years	Oregon Health and Science University

Spots Global Cancer Trial Database for interobserver agreement