Studies of Hyperparathyroidism and Related Disorders

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda
Time Frame
Start Date: 1993-12-15
Completion Date: 2020-12-23
Participants
Target number of participants: 1553
Treatments
No_intervention: Primary hyperparathyroidism
Patients with confirmed or suspected primary hyperparathyroidism or complications
Experimental: DOTATATE and F-DOPA
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA
Sponsors
Leads: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This content was sourced from clinicaltrials.gov