Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001277
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
1999-11-03
Brief Title:
Studies of Elevated Parathyroid Activity
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies of Hyperparathyroidism and Related Disorders
Status:
COMPLETED
Status Verified Date:
2022-02-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 glands parathyroidectomy Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact location of the tumor as well as the tumors 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 glands 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 PETCT MRI and CT scans and the number of lesions detected by each of these types of scans will be compared
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 glands parathyroidectomy Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact location of the tumor as well as the tumors 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 glands 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 PETCT 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 neoplasms 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 PETCT 18F-DOPA PETCT MRI and CT scans and the number of lesions detected by each of these types of scans will be compared
Clinical Trial An imaging substudy was added to this protocol in 2018 Patients with MEN1 will have 68Ga-Dotatate PETCT 18F-DOPA PETCT MRI and CT scans and the number of lesions detected by each of these types of scans will be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 91-DK-0085 | OTHER | NIH Clinical Center | None |