Studies of Elevated Parathyroid Activity
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Other Indications, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/22/2019 |
| Start Date: | March 31, 1991 |
| Contact: | William F Simonds, M.D. |
| Email: | wfs@helix.nih.gov |
| Phone: | (301) 496-9299 |
Studies of Hyperparathyroidism and Related Disorders
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.
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.
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).
(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).
- 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 exposure to, or usage of, any investigational product or device,
excluding 18F-DOPA scans, within 30 days prior to dosing
- Patients with known hypersensitivity to carbidopa, or who are concurrently taking a
nonselective monoamine oxidase (MAO) inhibitor..
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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