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:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT02967458
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be scheduled for a clinically indicated needle biopsy of the prostate based upon an elevated PSA, abnormal digital rectal examination, or based upon active surveillance of prostate cancer.
2. Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate.
3. Subject must be a male at least 18 years of age when informed consent is obtained.
4. Subject must have a life expectancy that exceeds the duration of the clinical trial.
Exclusion Criteria:
1. Participant in a clinical trial involving an investigational drug within the past 30 days.
2. Prior allergic reaction to the ultrasound contrast agent Definity™
3. Previous treatment for PCa.
4. Clinically unstable, severely ill, or moribund.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02967458
Study Brief:
Protocol Section:
NCT02967458