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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT02425956
Eligibility Criteria:
Inclusion Criteria
1. Be at least ten (10) years of age;
2. Have clinical history of iron overload;
3. If female of childbearing potential (not surgically sterile or post-menopausal), be determined non-pregnant by the medical co-investigator and/or a delegated physician on the study staff or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before participating in study procedures;
4. Provide evidence of willingness to participate by providing written informed consent to participate OR, if aged less than 18 years (\<18) be willing to provide written assent to participate and have parent(s) or legal guardian(s) willing to provide written informed consent for the subject's participation;
5. Be able to hear and understand instructions without assistive devices;
6. Have necessary mental capacity to understand instructions be able to comply with protocol requirements;
7. Be able to remain relatively motionless for the expected duration of imaging procedures (maximum of approximately 90 minutes).
Exclusion Criteria
1. Have medical history of present or prior focal liver disease, such as neoplasms or vascular abnormalities;
2. Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site;
3. Are scheduled for surgery, changes in dosage or type of chelating medications, or other medical interventions in between blood draw and MRI scanning that could be expected to impact study results or conduct;
4. Have had or plan to have a change in dosage or type of chelating medications (such as Deferoxamine or Deferasirox) within the 3 days prior to the first study procedure (blood draw or MRI, whichever comes first);
5. Are minor subjects with parent(s) or legal guardian(s) that require that they accompany the subject into the MR environment;
6. Have previously participated in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT02425956
Study Brief:
Protocol Section:
NCT02425956