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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02278367
Eligibility Criteria:
Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below.
Inclusion Criteria:
* Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study
Exclusion Criteria:
* Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
* Have a screening electrocardiogram with a corrected QT interval (QTc) \> 450 msec if male or QTc \> 470 msec if female
* Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval
* Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor
* Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
* Have a history of relevant severe drug allergy or hypersensitivity
* Are patients who have received an investigational medication within 30 days prior to the planned imaging session for this study
* Are patients with current clinically significant unstable medical comorbidities
* Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02278367
Study Brief:
Protocol Section:
NCT02278367