At a glance
ClinicalIndex Comparison Record- ✓Genetically confirmed MEN1 or clinical criteria of MEN1
- ✕Serious underlying medical conditions (renal failure, congestive cardiac failure) that restrict diagnostic testing or therapy
- ✕Pregnant or lactating women
- ✕Active concurrent infection
- ✕Known hypersensitivity to carbidopa or concurrent use of nonselective MAO inhibitor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Studies of Hyperparathyroidism and Related Disorders
In Brief
A Phase 2 clinical trial evaluating 68Ga-Dotatate and 18F-DOPA for Hyperparathyroidism and 4 related conditions. Completed, enrolled 1,553 participants across 1 site.
Detailed Summary
Observational Phase: Patients whose parathyroid activity is elevated above normal are referred to as having hyperparathyroidism. This study will help researchers better understand the causes of hyperparathyroidism and to evaluate and improve methods for diagnosis and treatment. Patients diagnosed with or suspected of having hyperparathyroidism will be selected to participate. In addition, patients with related conditions, such as parathyroid tumors, will also be selected. Subjects will be asked to provide blood and urine for testing to confirm their condition. They will then be surgically treated by removal of the parathyroid gland(s) (parathyroidectomy). Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact location of the tumor as well as the tumor's activity. The tests may include; ultrasounds, nuclear scanning, CT scans, MRI, and specialized blood testing. Sometimes parathyroidectomy leads to hypoparathyroidism. Options for treating the patients after the surgical procedure will also be addressed. Calcium and Vitamin D supplements are typically the mainstay of post parathyroidectomy therapy. Other potential treatments include transplanting the parathyroid gland(s) to other areas of the body. Clinical Trial: An imaging substudy was added to this protocol in 2018. Patients with multiple endocrine neoplasia type 1 (MEN1) will have 68Gallium-Dotatate Positron Emission Tomography (PET) - Computed Tomography (CT), 18F-DOPA PET/CT, MRI, and CT scans and the number of lesions detected by each of these types of scans will be compared.
Study Details
Timeline
Interventions
68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.
18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.