This study uses 64Cu PET/CT imaging to evaluate patients with Wilson disease who have previously received UX701 gene therapy. It enrolls people over 18 who received gene therapy as part of NCT04884815. This is a study with no assigned phase and is enrolling by invitation.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients with Wilson disease who have received gene therapy (UX701) as part of NCT04884815 * Age above 18 years * Women of childbearing potential must accept to use safe contraception at the time of the PET scans: Spiral or hormonal contraception (oral pills, implants, transdermal patches, vaginal rings, or depot injections) * At the day of the first PET scan, a negative urine pregnancy test is required for women of childbearing potential * Before the first PET scan, a signed informed consent must be completed Exclusion Criteria: * Known hypersensitivity to Cu-64, copper in general, or other components of the radiotracer formulation * Claustrophobia * Pregnancy, breastfeeding, or plans to become pregnant