Studies of Elevated Parathyroid Activity
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00001277 |
|
Recruitment Status :
Completed
First Posted : November 4, 1999
Results First Posted : June 7, 2022
Last Update Posted : June 7, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperparathyroidism Hypercalcemia Parathyroid Neoplasm Multiple Endocrine Neoplasia MEN1 | Drug: 68Ga-Dotatate Drug: 18F-DOPA | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1553 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Studies of Hyperparathyroidism and Related Disorders |
| Actual Study Start Date : | December 15, 1993 |
| Actual Primary Completion Date : | March 11, 2020 |
| Actual Study Completion Date : | December 23, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
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
|
Drug: 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. Drug: 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. |
- Type of Hyperparathyroidism [ Time Frame: First year ]
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.
- Organs With Identified Lesions [ Time Frame: Days 1-6 ]For each organ, agreement between 68Ga-DOTATATE and 18F-DOPA
- Number of Lesions Identified [ Time Frame: Days 1-6 ]The total number of lesions identified by each imaging modality
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 2 Months and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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..
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
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Smita Jha, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Documents provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00001277 |
| Other Study ID Numbers: |
910085 91-DK-0085 ( Other Identifier: NIH Clinical Center ) |
| First Posted: | November 4, 1999 Key Record Dates |
| Results First Posted: | June 7, 2022 |
| Last Update Posted: | June 7, 2022 |
| Last Verified: | February 7, 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
|
Hypoglycemia Genetics Hyperparathyroidism |
|
Endocrine Gland Neoplasms Multiple Endocrine Neoplasia Parathyroid Neoplasms Hypercalcemia Hyperparathyroidism Neoplasms Parathyroid Diseases Endocrine System Diseases |
Calcium Metabolism Disorders Metabolic Diseases Water-Electrolyte Imbalance Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Head and Neck Neoplasms |