Studies of Elevated Parathyroid Activity
Condition: Hyperparathyroidism; Hypercalcemia; Parathyroid Neoplasm; Multiple Endocrine Neoplasia; MEN1
MeSH terms: Endocrine Gland Neoplasms; Multiple Endocrine Neoplasia; Parathyroid Neoplasms; Hypercalcemia; Hyperparathyroidism
Intervention: 68Ga-Dotatate; 18F-DOPA
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1553.0
Sex: All
Minimum age: 2 Months
Healthy volunteers: No
Keywords: Hypoglycemia; Genetics; Hyperparathyroidism

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.
    

Eligibility criteria:

        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..