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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT01537159
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed or relapsed AML patients, who are scheduled to receive standard induction therapy.
* Age \> 8 years and requiring no sedation.
* Patients must not be pregnant
* Women of childbearing potential must have negative serum pregnancy test performed within 7-days prior to start of study
* The subject or subject's legal guardian has the ability to understand and the willingness to sign a written informed consent and/or assent document. A signed study-specific informed consent and/or assent must be obtained prior to any study specific procedures.
Exclusion Criteria:
* Patients who would be normally excluded from undergoing an MRI examination - patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
* Patients who have known or suspected allergy to gadolinium-based contrast agent.
* Severe claustrophobia precluding subject from undergoing a MRI
* Patients with acute or chronic kidney dysfunction (estimated Glomerular Filtration Rate (eGFR) \< 30ml/min/1.73 m2 as calculated using the Modification of Diet in Renal Disease (MDRD) Equation)
* Pregnant women are excluded from this study because of possible risk to the fetus.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
75 Years
Study:
NCT01537159
Study Brief:
Protocol Section:
NCT01537159