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 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT03097250
Eligibility Criteria:
Inclusion Criteria:
1. Age 12-25 years
2. Not currently participating in a clinical trial
3. Capable of providing informed assent/consent
4. Able to undergo MRI procedures without sedation
5. Does not have metal implants (braces or permanent retainers made of MRI-compatible materials are permitted since we will not be doing procedures, such as DTI, affected by non-ferrous metals).
6. PKU Group: identified by newborn screening; received treatment within the first 30 days of life
7. PKU Group: Pre-treatment/off-diet blood Phe concentration at or above 600 umol/L
Exclusion Criteria:
1. Older than 25 years or younger than 12 years of age.
2. Currently participating in a clinical trial
3. Incapable of providing informed assent/consent
4. Pregnant women will be excluded
5. Not able to tolerate MRI procedures without sedation
6. Has metal implants or braces on teeth not compatible with MRI
7. Has any known contraindication for MRI
8. PKU Group: Pre-treatment/off-diet blood Phe concentration below 600 umol/L)
9. PKU Group: Not identified through newborn screening or treatment was initiated after 30 days of life
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
25 Years
Study:
NCT03097250
Study Brief:
Protocol Section:
NCT03097250