Phase 2
N=1,553
Studies of Elevated Parathyroid Activity
Hyperparathyroidism · Hypercalcemia · Parathyroid Neoplasm · Multiple Endocrine Neoplasia · MEN1
Bottom Line
View on ClinicalTrials.gov: NCT00001277 ↗Enrolled (actual)
1,553
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Type of Hyperparathyroidism — 90; 276; 19; 61 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 68Ga-Dotatate (Drug); 18F-DOPA (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Type of Hyperparathyroidism |
90; 276; 19; 61; 116; 0 | — |
| PRIMARY Organs With Identified Lesions |
1; 0; 7; 8; 13; 0 | — |
| PRIMARY Number of Lesions Identified |
44; 1; 67; 22 | — |
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.
Eligibility 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..
Data sourced from ClinicalTrials.gov (NCT00001277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.