Studies of Elevated Parathyroid Activity
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|ClinicalTrials.gov Identifier: NCT00001277|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : March 12, 2020
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.
|Condition or disease|
|Hyperparathyroidism Hypocalcemia Parathyroid Neoplasm Multiple Endocrine Neoplasia MEN1|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Studies of Hyperparathyroidism and Related Disorders|
|Actual Study Start Date :||March 10, 1991|
Patients with confirmed or suspected primary hyperparathyroidism or complications therefrom (such as postoperative hypoparathyroidism) will be admitted for diagnosis and treatment.
- Evaluate natural history of hyperparathyroidism [ Time Frame: Yearly ]The purpose of this study is to understand the causes of primary hyperparathyroidism, to evaluate and improve methods for diagnosis and treatment, and to provide insight into the mechanisms of normal parathyroid function. Hereditary causes of primary hyperparathyroidism will be characterized. Methods of pre- operative parathyroid gland localization will be evaluated (6, 7, 8). Genes that contribute to development of parathyroid tumors will be analyzed (4, 9, 10).
- To compare the efficacy of 68Ga-Dotatate PET/CT scan versus 18F-DOPA PET/CT, MRI and CT scan [ Time Frame: Yearly ]To compare the efficacy of 68Ga-Dotatate PET/CT scan versus 18F-DOPA PET/CT, MRI and CT scan in detecting known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors in yearly intervals as per standard of care.
- To evaluate 68Gallium-Dotatate versus 18F-DOPA PET/CT uptake in NETs and its association with tumor differentiation [ Time Frame: Yearly ]There is the potential for direct benefit for patients participating in this study if the study results show 18F- DOPA PET/CT imaging to be more accurate than the current standard 68Gallium- DOTATATE at detecting primary lesions or metastasis. The future application of 18F- DOPA imaging modality in other patients could lead to early detection of solid gastrointestinal or pancreatic lesions and metastatic lesions, which would improve early management of these lesions and potentially have an impact on the overall course of the disease.
- To determine whether 68Gallium-Dotatate and/or 18F-DOPA PET/CT uptake value is predictive of tumor growth and/or disease progression and of its differentiation state. [ Time Frame: Yearly ]There is the potential for direct benefit for patients participating in this study if the study results show 18F- DOPA PET/CT imaging to be more accurate than the current standard 68Gallium- DOTATATE at detecting primary lesions or metastasis. The future application of 18F- DOPA imaging modality in other patients could lead to early detection of solid gastrointestinal or pancreatic lesions and metastatic lesions, which would improve early management of these lesions and potentially have an impact on the overall course of the disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001277
|Contact: William F Simonds, M.D.||(301) firstname.lastname@example.org|
|Contact: Jenny E Blau, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Jenny E Blau, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|