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 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT03270059
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have one of the following:
* Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.)
* Radiological abnormalities in the brain (neoplastic or non-neoplastic in nature)
* Neoplastic process elsewhere in the body that may affect the brain (i.e. possible metastasis, vascular compromise, treatment related changes, etc.)
* Subjects must be able to undergo MRI imaging without anesthesia
* Subjects must be at least 10 years of age
* All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
* Sexually active women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; post-menopausal \< 6 months; or abstinence) for at least two months after each cycle of the study; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Exclusion Criteria:
* Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
* Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2009); subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion
* Subjects who are pregnant or lactating or who suspect they might be pregnant
* Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
* Subjects with known iron overload (genetic hemochromatosis); in subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: transferrin saturation (TS) test and serum ferritin (SF) test; all associated costs will be paid by the study
* Subject who have received ferumoxytol within 3 weeks of study entry
* Subjects with three or more drug allergies from separate drug classes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT03270059
Study Brief:
Protocol Section:
NCT03270059