Bethesda, Maryland 20892

  • MEN1

Purpose:

Patients whose parathyroid activity is elevated above normal are referred to as having hyperparathyroidism. This study will help researchers better understand the causes of hyperthyroidism and to evaluate and improve methods for diagnosis and treatment. In this study, 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.


Study summary:

Patients with confirmed or suspected primary hyperparathyroidism or complications therefrom (such as postoperative hypoparathyroidism) will be admitted for diagnosis and treatment. The principal diagnostic components are calcium in serum and urine, parathyroid hormone in serum, and mutation tests on germline or tumor DNA. Patients with moderately to severe primary hyperparathyroidism will be treated. Treatment will be mainly by parathyroidectomy. Preoperative testing to localize parathyroid neoplasm(s) will be used usually and with more extended methods in cases with prior neck surgery. Other options are medications or no intervention. Patients with a hyperparathyroid syndrome may be managed for their extraparathyroid features (medical management or surgical treatment). Preoperative tumor localization tests will be selected according to clinical indications from the following: ultrasound, technetium-thallium scan, computerized tomography, magnetic resonance imaging, somatostatin receptor imaging, fine needle aspiration for parathyroid hormone assay, selective arteriogram, selective venous catheterization for parathyroid hormone assay. Options for management of postoperative hypocalcemia include calcium, vitamin D analogs, parathyroid autografts and synthetic parathyroid hormone. Research specimens may consist of blood or tumors. In addition, a substudy for patients with multiple endocrine neoplasia type 1 (MEN1) will assess the utility of two PET/CT scans with radiotracers (68Gallium-DOTATATE and 18F-DOPA).


Criteria:

- INCLUSION CRITERIA: - Patients who have genetically confirmed MEN1 or clinical criteria of MEN1. - Age greater than age 18. - 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..


NCT ID:

NCT00001277


Primary Contact:

Principal Investigator
Jenny E Blau, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

William F Simonds, M.D.
Phone: (301) 496-9299
Email: wfs@helix.nih.gov


Backup Contact:

Email: jenny.blau@nih.gov
Jenny E Blau, M.D.
Phone: (301) 827-1930


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone: 800-411-1222
Email: prpl@cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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