Have you or your loved ones been diagnosed with hyperparathyroidism?

You may be eligible to participate in a hyperparathyroidism clinical trial.

Have you or your loved ones been diagnosed with hyperparathyroidism? You may be eligible to participate in a hyperparathyroidism clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Hyperparathyroidism Clinical Trial in Bethesda MD

NCT00001277 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with hyperparathyroidism?

You may be eligible to participate in a hyperparathyroidism clinical trial.

Have you or your loved ones been diagnosed with hyperparathyroidism? You may be eligible to participate in a hyperparathyroidism clinical trial.

Completed

Male & Female

2 Months +

This study has recruited 1553 Participants

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.

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Details for the study

Brief Title

Studies of Elevated Parathyroid Activity

Official Title

Studies of Hyperparathyroidism and Related Disorders

Brief 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.

Detailed Description

Observational: 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
moderate to severe primary hyperparathyroidism will be treated. Treatment will be mainly by
parathyroidectomy. Other options are medications or no intervention. Patients with a
hyperparathyroid syndrome may be managed for their extraparathyroid features. Preoperative
testing to localize parathyroid neoplasm(s) will be used usually and with more extended
methods in cases with prior neck surgery. Preoperative tumor localization tests will be
selected according to clinical indications from the following: ultrasound,
technetium-thallium scan, computerized tomography, magnetic resonance 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.

Clinical Trial: An imaging substudy was added to this protocol in 2018. Patients with MEN1
will have 68Ga-Dotatate PET/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.

Treatments and/or Procedures

68Ga Dotatate

68Ga-Dotatate PET/CT will be administered prior to a PET/CT scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.

18F DOPA

18F-DOPA PET/CT will be administered prior to a whole-body scan to detect known and occult primary and metastatic bronchial, gastrointestinal and pancreatic neuroendocrine tumors.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Type of Hyperparathyroidism

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. Patients were categorized as follows: MEN1: Diagnosed by demonstration of a germline variant in MEN1 gene or one of the following: a) two of three primary MEN1 manifestations b) one primary MEN1 manifestation with a family member with MEN1. Other familial: Non-MEN1 patients who had a positive family history of hyperparathyroidism suspicious for underlying germline predisposition syndrome. Sporadic: Patients who did not have a positive family history of hyperparathyroidism. Unknown: No data to help categorize the patients in any of the above categories.

First year

Primary

Organs With Identified Lesions

For each organ, agreement between 68Ga-DOTATATE and 18F-DOPA

Days 1-6

Primary

Number of Lesions Identified

The total number of lesions identified by each imaging modality

Days 1-6

Study Criteria

INCLUSION CRITERIA:

  -  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

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..