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This study evaluates the imaging agents 68Ga-Dotatate and 18F-DOPA in people with elevated parathyroid activity. Participants are patients with genetically confirmed or clinically diagnosed MEN1 (Multiple Endocrine Neoplasia type 1). It was a Phase 2 study and has been completed.
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 who have genetically confirmed MEN1 or clinical criteria of MEN1. * For females: Negative urine pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy EXCLUSION CRITERIA: * Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure or congestive cardiac failure * Patients unable or unwilling to give informed consent * Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 68Ga-DOTATATE in pregnancy are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68Ga-DOTATATE in the mother, women who are breastfeeding are also excluded from this study * Patients that have recognized concurrent active infection * Patients with known hypersensitivity to carbidopa, or who are concurrently taking a nonselective monoamine oxidase (MAO) inhibitor..