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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT03882359
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects 19 years of age or older, male or female
* Female subjects must no longer have child-bearing potential (\>1-year post menopause or surgically sterilized), or must
* have a negative urine pregnancy test, and
* be using and continue to use for 30 days after the study a medically effective method of contraception
* Adequate hematologic, renal and hepatic function, as defined by:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Hemoglobin ≥ 90 g/L
* Plasma creatinine\< 1.5 x ULN
* Total bilirubin within normal limits (\< 2.5 x ULN if Gilbert's syndrome)
* Aspartate transaminase (AST) and Alanine transaminase (ALT) \< 2.5 x ULN
* Subject must be willing and able to understand the study and provide written Informed Consent to participate in the study
Exclusion Criteria:
* Myocardial infarction within six months prior to enrollment
* Unstable angina, NYHA Class II or greater congestive heart failure
* EKG evidence of uncontrolled arrhythmia or history of clinically significant arrhythmia within the past six months
* Clinically significant Chronic Obstructive Pulmonary Disease (COPD) or other pulmonary condition that is not controlled by medication or requires oxygen frequently or continuously
* A history of pulmonary emboli
* Known hypersensitivity to perflutren, DEFINITY® or other echo contrast agent
* Inability to remain supine for 60 minutes
* Oxygen saturation \< 95% on room air
* History of allergic reaction attributed to compounds of similar chemical composition to MVT-100 or DEFINITY® or soy or egg allergies (see Investigator's Brochure)
* Subject has received any investigational drug within thirty (30) days prior to enrollment into the study
* Inability to comply with study procedures
* Subjects with any medical condition deemed by the investigator to make the subject inappropriate for participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03882359
Study Brief:
Protocol Section:
NCT03882359