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Protocol Summary


Protocol No.
PSCI-21-042
Prinicipal Investigator
Sarwani, Nabeel
Phase
Phase IV
Age Group
Adult
Scope
National
Title
Prospective evaluation of potential effects of repeated gadoliniumbased contrast agent (GBCA) administrations of the same GBCA on motor and cognitive functions in neurologically normal adults in comparison to a non-GBCA exposed control group ODYSSEY
Objective
Primary Objective:
To prospectively assess the potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA exposed control group.
Secondary Objectives:

To assess the change from baseline in the composite endpoints (motor and cognitive) at each of the post-baseline time points (Years 1 to 4) in GBCA-exposed participants as compared to controls.

To assess the change from baseline for each of the individual tests (motor and cognitive) at each of the post-baseline time points (Years 1 to 5) in GBCA-exposed participants as compared to controls.

To evaluate safety through collection of adverse events.

To assess total Gd concentrations (as measured in a central laboratory) in blood and urine samples taken from exposed and control participants at the time of annual visit.
Applicable Disease Sites
Breast

Colon

Liver

Prostate
Status
Open
Participating Institutions
Hershey Medical Center