Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients receive sonazoid ID and undergo ultrasound imaging. Patients also undergo standard of care SLNB.

Sentinel Lymph Node Biopsy

Undergo sonazoid-enhanced ultrasonography

Ultrasonography

Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.

Sonazoid

Kevin King, MD

This pilot phase I trial studies how well sonazoid-enhanced ultrasound works in detecting sentinel lymph node in patients with cutaneous melanoma. Sonazoid is a contrast agent that may make it easier to see if the tumor cells have spread to the sentinel lymph node using an ultrasound.

PRIMARY OBJECTIVES:

I. To study the imaging feasibility of peri-tumoral administration of sonazoid ultrasound contrast agent for assessment of sentinel lymph node (SLN) detection in melanoma.

II. To compare SLN detection between sonazoid ultrasound and standard of care (SOC) technique.

SECONDARY OBJECTIVES:

I. To assess the sonazoid ultrasound (US) imaging appearance of lymph nodes which are shown to be involved with metastatic disease.

OUTLINE:

Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging. Patients also undergo standard of care sentinel lymph node biopsy (SLNB).

After completion of study treatment, patients are followed up at 24 and 48 hours.

Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma

Pilot Translational Study of Sonazoid-Enhanced Ultrasonography for Sentinel Lymph Node Mapping in Cutaneous Melanoma

National Cancer Institute (NCI)

University of Southern California

Digestive System Diseases

Infections

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Hepatitis A

Hepatitis C

Hepatitis

Liver Cirrhosis

Hepatitis B

Liver Neoplasms

Fibrosis

Neoplasms, Glandular and Epithelial

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Virus Diseases

Communicable Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Blood-Borne Infections

Flaviviridae Infections

Hepadnaviridae Infections

DNA Virus Infections

Hematinics

All Drugs and Chemicals

Liver Extracts

screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months

screening by conventional B-mode US every 3-5 months

CE-US (Sonazoid™)

B-mode US

Masatoshi Kudo, professor

Kazuomi Ueshima, lecturer

The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by CE-US has a survival benefit than that by B-mode US.

Sonazoid Enhanced Liver Cancer Trial for Early Detection

Kindai University

Japan Liver Oncology Group

Oculocerebral Syndrome With Hypopigmentation

Sonazoid (perflubutane) \[GE healthcare\]

Sonazoid-enhanced ultrasonography

B-mode ultrasonography (B-US), a standard method of surveillance of hepatocellular carcinoma (HCC), has a fair sensitivity of 63% in detecting early stage HCC. Sonazoid, a contrast agent for ultrasonography, has reported to have superior sensitivity in detecting focal liver lesion since it has ability of Kupffer phase imaging as well as vascular phase imaging. So our aim is to compare the detection rate of early stage HCC and false referral rate of HCC between B-mode US and Sonazoid-enhanced ultrasonography (S-US) within the same prospective data group. Our hypothesis is that S-US has superior detection rate of early stage HCC (5%) than that of B-mode US (3%).

Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study

Detection rate of early-stage HCC = (Number of confirmed early-stage HCC detected by a given modality) / (Total number of patients enrolled) x100

GE Healthcare

Yonsei University

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Nasopharyngeal Carcinoma

Neoplasm Metastasis

Lymphatic Metastasis

Neoplastic Processes

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

All patients enrolled will undergo an MRI Scanning and CEUS to evaluate their cervical lymph nodes. Ultrasound-guided lymph node aspiration and pathologic examination will be performed subsequently to obtain definitive diagnosis of the lymph nodes. The pathologic results of the lymph nodes will be adopted as gold standard to evaluate the diagnostic performance of MRI Scanning, CEUS, and the combined diagnostic criteria.

MRI scanning will be performed with a 3.0-T magnetic resonance imaging system with a head and neck-combined coil employing spin-echo technique. The range of the MRI scanning will be from the suprasellar cistern to the inferior margin of the sternal end of the clavicle. The section thicknesses for the axial plane, the sagittal plane and the coronal plane will be 5 mm, 3 mm and 2 mm, respectively. The intersection gaps will be 1 mm. Before the intravenous injection of the MRI contrast agents, T1 weighted images, T2 weighted images and diffusion weighted images will be obtained in the axial planes, while only T1 weighted images will be obtained in the sagittal and coronal planes. After the intravenous injection of the MRI contrast agents, T1-weighted axial sequence, T1-weighted sagittal sequences and T1-weighted fat-suppressed coronal sequence will be performed.

MRI Scanning

A sonographer equipped with a 6-15 MHz linear array probe will be adopted for contrast-enhanced ultrasonography examination. Conventional high-frequency ultrasonography will be performed firstly before the intravenous injection of the ultrasound contrast agents. Then the ultrasound contrast agents will be injected intravenously, and contrast-enhanced ultrasonography examination will be performed. The mechanical index of contrast-enhanced ultrasonography examination will be 0.23. The wash-in and wash-out process within the lymph node will be dynamically observed during the arterial phase. During the Kupffer-phase, the degree of enhancement will also be observed.

Contrast-Enhanced Ultrasonography

After the conventional high-frequency ultrasonography and contrast-enhanced ultrasonography examination was finished, ultrasound-guided aspiration of the target lymph node will be performed. The lymph node tissue obtained from ultrasound-guided lymph node aspiration will be subjected to pathologic evaluation. And the diagnostic performance of MRI and contrast-enhanced ultrasonography will be evaluated using the pathologic diagnosis of the lymph node as the gold standard.

Ultrasound-guided Lymph Node Aspiration

Jun Ma, M.D.

Kaibin Yang, M.D.

This is a single-center diagnostic accuracy study, with the purpose to define the criteria to diagnose small cervical lymph node metastases in patients with nasopharyngeal carcinoma by combining MRI scanning and contrast-enhanced ultrasonography and evaluate the diagnostic performance of the criteria.

For newly diagnosed and histologically confirmed nasopharyngeal carcinoma patients staged as T1-4, N0-1/N3, M0 (AJCC 8th), if no metastatic lymph nodes were found on MRI according to the current diagnostic criteria, but there were small lymph nodes with a minimal axial diameter ≥ 5 mm (6 mm for lymph node in level IIA) on at least one side of the patient's neck, they will be eligible for this study. The MRI image of the small lymph nodes will be evaluated in details by experienced radiologists. Contrast-enhanced ultrasonography with specific ultrasound contrast agents (Sonazoid) and ultrasound-guided lymph node aspiration will be performed. Subsequently, the lymph node tissue obtained from ultrasound-guided lymph node aspiration will be subjected to pathologic evaluation. Using the pathologic diagnosis of the lymph node as the gold standard, diagnostic performance of MRI and contrast-enhanced ultrasonography will be evaluated. Resonable criteria to diagnose small cervical lymph node metastases by combining MRI scanning and contrast-enhanced ultrasonography will be explored. And the diagnostic performance of the criteria will be evaluated.

Combining MRI and CEUS to Diagnose Small Cervical Lymph Node Metastases in NPC Patients

Combining MRI Scanning and Contrast-Enhanced Ultrasonography to Diagnose Small Cervical Lymph Node Metastases in Patients With Nasopharyngeal Carcinoma

The criteria to diagnose small cervical lymph node metastases in patients with nasopharyngeal carcinoma by combining MRI scanning and contrast-enhanced ultrasonography with specific ultrasound contrast agents (Sonazoid).

The receiver operating characteristic curve of each characteristics of small lymph nodes in MRI scanning and CEUS examination will be plotted. The area under the curve will be calculated. And the optimal cut-off value of each characteristics will be determined based on the receiver operating characteristic curve.

The diagnostic performance of each characteristics of small lymph nodes in MRI scanning and CEUS examination will be evaluated with sensitivity, specificity, Youden index, accuracy, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio.

The inter-operator agreement of qualitative characteristics of small lymph nodes in MRI scanning and CEUS examination will be evaluated with Cohen's kappa coefficient. The inter-operator agreement of quantitative characteristics of small lymph nodes in MRI scanning and CEUS examination will be evaluated with Bland-Altman analysis and paired t-test.

The diagnostic performance of the combined diagnostic criteria will be evaluated with area under the receiver operating characteristic curve, Youden index, accuracy, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio.

The inter-operator agreement of the combined diagnostic criteria will be evaluated with Cohen's kappa coefficient.

Sun Yat-sen University

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Renal Insufficiency

Comparison of Sonazoid enhanced ultrasound to non enhanced CT

Patients with renal failure or other reason for contraindication for contrast enhanced computed tomography (CECT) or contrast enhanced magnetic resonance imaging (CEMRI) with suspected liver pathology will be evaluated with Sonazoid enhanced Ultrasound

Patients with a diagnosis of cancer or high probability of cancer (any primary) who have contraindications for a contrast enhanced Computed Tomography or Magnetic Resonance Image will be asked to participate in this study. Patients will be both male and female and be \>18 years old. Contraindications for computer tomography (CT) or magnetic resonance imaging (MRI) would include, but not limited to:

1. Creatinine clearance of \<60 mg/dl
2. Allergy to iodinated contrast or gadolinium based contrast agents
3. History of adverse event with CT or MRI contrast

Up to 100 patients will be enrolled over a two year period.

Statistical justification for sample size Assuming that a non-enhanced CT will detect and characterize metastatic disease correctly 60% of the time (2) and that Contrast enhanced ultrasound (CEUS) will detect and characterize metastatic disease correctly 90% of the time (3,4), there will be a 100% chance of a significant difference at a one-sided 0.05 significance level using the Fisher Exact Test.

CT and MRI Patient will receive the non-contrast CT or MRI that would be ordered as routine stating or follow-up of the patient. At a minimum 5mm contiguous axial slices will be obtained with CT and T1-weighted, T2-weighted, in-phase and out of phase imaging will be performed on MRI with a minimum slice thickness of 5mm. Each lesion noted within the liver will be measured in two dimensions and recorded. The lesion will be classified on a scale of 1 - 5 regarding the probability of benignity or malignancy of the lesion. If a diagnosis can be made the diagnosis will be documented The location of the lesion will be documented on a Couinaud diagram.

CEUS-Contrast specific software optimized for Sonazoid will be used or both vascular and Kupffer phase imaging. The focus will be set below the lesion of interest for vascular phase imaging and at 4-8 cm for the left lobe and 8-10 cm for the right lobe for Kupffer phase imaging. The lesion of interest was imaged from 15 seconds before injection to 1 minute after injection (vascular phase imaging). No further scanning will be performed until the Kupffer phase imaging, which will begun 10 minutes after the injection.

The patient will receive the following ultrasound imaging:

1. Standard B-mode and color-Doppler imaging. Elastography may be added at PI's discretion.
2. A 20g IV will be placed in an antecubital vein
3. Low MI scan will be used in the vascular phase.
4. An intermediate MI scan will be used after at least a 10 minute delay to perform the Kupffer scan
5. If a lesion is identified on the Kupffer scan which is not characterized by the without exam the patient will have a complete evaluation of the vascular phase a second injection may be used.

Each lesion noted within the liver will be measured in two dimensions and recorded. The lesion will be classified on a scale of 1 - 5 regarding the probability of benignity or malignancy of the lesion. If a diagnosis can be made the diagnosis will be documented. The location of the lesion will be documented on a Couinaud Diagram.

The gold standard will be either

1. characteristic enhancement pattern (hemangioma, benign)
2. lesion biopsy
3. growth of the lesion over a 6 month period of time (malignant)

Data Analysis

For assessment of characterization efficacy the McNemar test will be used to compare the rates of correct diagnosis for lesions on unenhanced ultrasound, CEUS and unenhanced CT or MRI. For assessment of detection efficacy, Wilcoxon's signed rank test will be used to compare the lesion detection rates obtained with unenhanced ultrasound, CEUS, and unenhanced CT or MRI. For all tests, p\<0.05 will be considered a statistically significant difference.

Evaluation of Suspected Liver Pathology in Patients With Contraindications for Contrast Enhanced CT and/or MRI

Evaluation of Suspected Liver Pathology in Patients With Contraindications for Contrast Enhanced Computed Tomography and/or Magnetic Resonance Imaging Using Sonazoid

Determination of the liver lesion detection rate of Sonozoid

Determine the accuracy of liver lesion characterization by Sonozoid

Evaluate the Adverse event rate using Sonozoid

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma	NCT02968680	Cutaneous Melan... Melanoma	Sentinel Lymph ... Ultrasonography Sonazoid	19 Years -	University of Southern California
Sonazoid Enhanced Liver Cancer Trial for Early Detection	NCT00822991	Hepatocellular ... Liver Cirrhosis Hepatitis B Hepatitis C	CE-US (Sonazoid... B-mode US	20 Years -	Kindai University
Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study	NCT02188901	Hepatocellular ...	Sonazoid-enhanc...	20 Years -	Yonsei University
Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study	NCT02188901	Hepatocellular ...	Sonazoid-enhanc...	20 Years -	Yonsei University
Combining MRI and CEUS to Diagnose Small Cervical Lymph Node Metastases in NPC Patients	NCT05389306	Nasopharyngeal ...	MRI Scanning Contrast-Enhanc... Ultrasound-guid...	18 Years - 70 Years	Sun Yat-sen University
Evaluation of Suspected Liver Pathology in Patients With Contraindications for Contrast Enhanced CT and/or MRI	NCT02651090	Liver Metastasi... Liver Mass	Sonazoid	18 Years - 100 Years	Northeastern Ohio Radiology Research and Education Fund
Sonazoid-Enhanced Ultrasound in Detecting Sentinel Lymph Node in Patients With Cutaneous Melanoma	NCT02968680	Cutaneous Melan... Melanoma	Sentinel Lymph ... Ultrasonography Sonazoid	19 Years -	University of Southern California

Spots Global Cancer Trial Database for sonazoid

Every month we try and update this database with for sonazoid 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 sonazoid

Every month we try and update this database with for sonazoid 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 sonazoid 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.