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Protocol Details

Studies of Hyperparathyroidism and Related Disorders

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

91-DK-0085

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 2 Months
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Hypoglycemia;
Genetics;
Hyperparathyroidism

Recruitment Keyword(s)

None

Condition(s)

Hyperparathyroidism;
Hypercalcemia;
Parathyroid Neoplasm;
Multiple Endocrine Neoplasia;
MEN1

Investigational Drug(s)

68Ga-DOTATATE
[18F]-DOPA

Investigational Device(s)

None

Intervention(s)

Drug: 68Ga-Dotatate
Drug: 18F-DOPA

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

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.

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Eligibility

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..


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Smita Jha, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 9C432A
10 CENTER DR
BETHESDA MD 20814
(301) 827-1930
smita.jha@nih.gov

William F. Simonds, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 8C101
10 CENTER DR
BETHESDA MD 20814
(301) 496-9299
bills@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00001277

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