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NCT00001277 · ClinicalTrials.gov registry record · Phase 2
Studies of Elevated Parathyroid Activity
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 1,553
- Enrollment target
NCT00001277 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 1,553 participants.
The verdict
NCT00001277, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,553 participants
- Enrollment target
Study 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.
Interventions
- DRUG 68Ga-Dotatate
- DRUG 18F-DOPA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,553 participants |
| Start Date | 1993-12-15 |
| Est. Completion | 2020-12-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001277
The ClinicalTrials.gov registry entry for NCT00001277 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,553 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 68Ga-Dotatate is the first listed.
NCT00001277 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001277 about?
NCT00001277 is a clinical study titled "Studies of Elevated Parathyroid Activity". 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 wi...
What is the current status of trial NCT00001277?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,553 participants. The study started on 1993-12-15. Estimated completion is 2020-12-23.
What interventions are being tested in trial NCT00001277?
The interventions under investigation include: 68Ga-Dotatate (DRUG), 18F-DOPA (DRUG).
Who is sponsoring clinical trial NCT00001277?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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