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Patients with Von-Hippel Lindau disease will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.

Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.

Perflutren lipid microsphere

Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Lumason will be used as a secondary contrast agent only if Definity(perflutren) is unavailable.This drug will be administered using the dosing range and administration type within the Lumason prescribing information. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.

Sulfur hexafluoride lipid microspheres

Emily Chang, MD

The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with Von-Hippel Lindau with the same accuracy as conventional ultrasound and contrast-enhanced magnetic resonance imaging (MRI)

This is a pilot cross-sectional study that compares contrast enhanced ultrasound to conventional ultrasound and contrasted MRI. Any patient undergoing annual imaging screening is eligible, but the investigators will target inclusion of at least 10 subjects who have at least 1 kidney lesion. Therefore, up to 5 subjects may have no current kidney lesions. Subject participation will be only for the day of CEUS study. There will be no follow-up period for this study. However, if results are encouraging, a longitudinal observational study may follow, and these same subjects would be eligible for enrollment. Eligible subjects will undergo a contrast enhanced ultrasound.

Following completion of imaging, all CEUS, MRI (within 4 months) and B-mode (at time of CEUS) US studies will be de-identified. Blinded radiologists will interpret images and provide an overall assessment of risk of malignancy to each kidney using the Bosniak criteria for each kidney lesion present. The Bosniak criteria places cystic lesions into one of 5 categories (I, II, IIF, III and IV) based on lesion characteristics. CEUS based diagnosis will be compared to the diagnoses on routine B-mode US and contrast-enhanced MRI.

Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau

Double-Center Cross-Sectional Study of Contrast-Enhanced Ultrasound With Lumason/Definity as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau

Each reader will evaluate kidney imaging using Contrast-Enhanced Ultrasound (CEUS) versus Brightness Mode Ultrasound (B-mode) in patients at risk for kidney lesions. A dichotomized Bosniak score was used for comparison. Dichotomized Bosniak score: 0= nonmalignant and 1=malignant or possibly malignant. Scores were averaged across all readers. Kidneys were assessed by CEUS and B-mode by three different readers.

Each reader will evaluate kidney imaging using Contrast-Enhanced Ultrasound (CEUS). Potentially malignant lesions were extracted from clinically performed magnetic resonance imaging (MRI) completed within 4 months of CEUS. Dichotomized Bosniak scores from CEUS were compared with MRI-derived malignancy scores.

Dichotomized Bosniak scores: 0= nonmalignant and 1=malignant or possibly malignant. Scores were averaged across all readers.

Lantheus Medical Imaging

UNC Lineberger Comprehensive Cancer Center

Adverse events were collected from day one of the study contrast agent administration.

Patients with a genetic disease at risk of kidney lesions will be imaged using contrast-enhanced ultrasound with Perflutren.

Patients With a Genetic Disease at Risk of Kidney Lesions

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Patients with a genetic disease at risk of kidney lesions will be imaged using contrast-enhanced ultrasound with Perflutren and their clinical MRI images performed within 4 months.

Melahat Canter

Contrast-enhanced ultrasound (CEUS) technique was used to evaluate 29 kidneys belonging to 15 subjects.

CEUS

Brightness Mode Ultrasound (B-mode) technique was used to evaluate 29 kidneys belonging to 15 subjects.

B-Mode

Patients with a genetic disease at risk of a kidney lesion were imaged using contrast-enhanced ultrasound with Perflutren and B-mode ultrasound. Twenty- nine kidneys belonging to fifteen patients were assessed.

Comparison in Radiologist's Lesion Evaluation: CEUS Versus B-mode Ultrasound

Magnetic Resonance Imaging was used to evaluate 29 kidneys belonging to 15 subjects.

Magnetic Resonance Imaging

Patients with a genetic disease at risk of kidney lesions will be imaged using contrast-enhanced ultrasound with Perflutren.Twenty- nine kidneys belonging to fifteen patients were assessed.

Comparison in Radiologist's Lesion Evaluation: CEUS Versus Clinically Performed MRI

All Patients with genetic diseases at risk of kidney lesions.

All Subjects

Overall Study Subjects

B Mode

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Diabetes Mellitus

COVID-19

Hypertension

Respiration Disorders

Respiratory Tract Diseases

Noncommunicable Diseases

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

The intervention of the study is the COVID-19 outbreaks in Hong Kong. The pre-and post-COVID-19 outbreak periods will be defined as 1 January 2010 - 31 December 2019 and 1 January 2020 - 31 December 2024, respectively.

COVID-19 outbreaks

Cindy L.K. Lam, MD

Eric Y.F Wan, PhD

Objectives and aim: To evaluate the long-term spill-over (indirect) effect of Coronavirus disease (COVID-19) on health outcomes and healthcare utilization among people with non-communicable diseases and without COVID-19.

Design: A population-based cohort study using electronic health records of the Hospital Authority (HA) clinical management system, economic modeling, and serial cross-sectional surveys on healthcare service utilization.

Setting: HA public hospitals and outpatient clinics in Hong Kong

Participants: People aged ≥ 18 years with a documented diagnosis of diabetes mellitus, hypertension, cardiovascular disease, cancer, chronic respiratory disease, and chronic kidney disease; without COVID-19; attending HA services between 2010 and 2024.

Main outcome measures: All-cause mortality, disease-specific outcomes, healthcare service utilization, and costs.

Methods: The annual incidence of each outcome in each year between 2010 and 2024 will be calculated. An interrupted time-series analysis to assess the changes in outcomes between pre-and-post-COVID-19 outbreak periods. Long term health economic impact of healthcare disruptions during the COVID-19 outbreak will be modeled using microsimulation. Multivariable Cox proportional hazards regression and Poisson/negative binomial regression to evaluate the effect of different modes of care on the risk of the outcomes.

Implications: Findings will inform policies and practices on contingency care plans to avoid excessive morbidity and mortality and to assure the quality of care for patients with NCD as part of the territorial response to the health crisis.

This study aims to evaluate the spill-over impact of the COVID-19 outbreak on health outcomes, healthcare utilization, and costs in patients with major non-communicable diseases (NCDs). The study will include six leading NCDs (diabetes mellitus, hypertension, cardiovascular diseases (CVD), cancer, chronic kidney diseases (CKD), chronic respiratory diseases) representing the most prevalent conditions and the major causes of deaths in Hong Kong. The objectives of the study are the following:

1. To determine changes in all-cause mortality, disease-specific outcomes, and healthcare utilization rates and costs among major NCD patients during the pre-and post- COVID-19 outbreak.
2. To assess the long-term health economic impact of COVID-19 on health outcomes and healthcare utilization rates and costs among major NCD patients by conducting an in-depth economic evaluation
3. To explore the impact of different modes of care on all-cause mortality, disease-specific outcomes, and healthcare utilization rates and costs among major NCD patients during the post-COVID-19 period.

This study consists of two study designs.

1. It is a retrospective cohort study using data extracted from the electronic medical records of the Hong Kong Hospital Authority (HA) Clinical Management System (CMS) from 1 January 2010 to 31 December 2024.

   * Anonymous data including socio-demographics, disease-specific parameters identified by International Classification of Primary Care, 2nd edition (ICPC-2) and the International Classification of Diseases, 9th revision, Clinical Modification (ICD-9-CM) will be extracted by the Hospital Authority statistics. There will be two phases of data extraction for the data collected in the periods 2010-2021 and 2022-2024.
2. The investigators will carry out two serial cross-sectional surveys on self-reported healthcare service utilization in the second and fourth years after the COVID-19 outbreak.

   * Two surveys will be conducted for patients with the major NCD recruited from outpatient clinics to collect data on healthcare service utilization patterns and rates in the years of 2020 and 2022 using a structured questionnaire.

The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of People With Non-communicable Diseases

The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of Patients With Non-communicable Diseases (and Without COVID-19) : an In-depth Outcome and Health Economic Evaluation

Years of life lost (YLL), quality-adjusted life year (QALY), and disability-adjusted life year (DALY) attributable to delayed care resulting from the COVID-19 outbreak. Based on life expectancy for 10-year ages groups from the Census and Statistics Department life tables for 2017-19.

Incidence of all-cause mortality, and disease-specific complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality) The disease are defined by the diagnosis codes International Classification of Primary Care, Second edition or International Classification of Diseases,Ninth Revision, Clinical Modification.

Utilization rates and costs for public and private healthcare services including hospitalization (episodes, modes of admission and length of stay), specialist and general outpatient consultations (number of visits, modes of consultations, western/Chinese medicine), and Accident \& Emergency Department (AED) attendances (triage urgency level for AED attendances at public hospital).

The University of Hong Kong

Clinical Professor, Chairperson of Department of Family Medicine & Primary Care

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau	NCT03907657	Von-Hippel Lind... Kidney Disease,...	Perflutren lipi... Sulfur hexafluo...	16 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center
Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau	NCT03907657	Von-Hippel Lind... Kidney Disease,...	Perflutren lipi... Sulfur hexafluo...	16 Years - 99 Years	UNC Lineberger Comprehensive Cancer Center
The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of People With Non-communicable Diseases	NCT05248412	Diabetes Mellit... Hypertension Cancer Cardiovascular ... Chronic Respira... Kidney Disease,... Noncommunicable...	COVID-19 outbre...	18 Years -	The University of Hong Kong

Spots Global Cancer Trial Database for kidney disease, chronic