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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT03565367
Eligibility Criteria:
Inclusion Criteria:
* Patients with a known diagnosis of central nervous system (CNS) malignancy, including metastases, with known enhancement on magnetic resonance (MR) who are otherwise eligible to undergo MRI
* Glomerular filtration rate (GFR) \> 30 ml/min
* No allergy to gadolinium
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Refusal to have an IV placed for injection
* Acute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator?s judgement
* Total bilirubin \> 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2.5 x ULN
* Gamma-glutamyltransferase (GGT) \> 2.5 x ULN
* Pregnant or breast-feeding
* Cardiovascular risk, including:
* Poorly controlled hypertension, defined as either systolic \> 170 or diastolic \> 110
* Congestive heart failure
* Myocardial infarction within the past year
* QT prolongation, defined as pretreatment corrected QT interval (QTc) \> 440 msec in males or \> 460 msec in females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03565367
Study Brief:
Protocol Section:
NCT03565367