Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT03907657
Eligibility Criteria:
Inclusion Criteria:
To be eligible for the present study, patients must meet the following criteria:
1. Able to provide written informed consent
2. Willing to comply with protocol requirements
3. At least 16 years of age
4. Carry a diagnosis of VHL and able to undergo routine clinical screening tests for RCC
Exclusion Criteria:
1. Critically ill or medically unstable or in an intensive care setting and whose critical course during the observation period would be unpredictable
2. Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®)
3. Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure \>90mmHg), or adult respiratory distress syndrome
4. Active cardiac disease including any of the following:
A. Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association) B.Unstable angina. C.Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation).
D.Myocardial infarction within 14 days prior to the date of proposed microbubble administration.
5. Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:
* Mental illness
* Drug abuse
6. Female patient who is pregnant or lactating
7. Obesity that limits obtainment of acceptable images
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
99 Years
Study:
NCT03907657
Study Brief:
Protocol Section:
NCT03907657