Studies of Elevated Parathyroid Activity

NCT00001277 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 91008591-DK-0085
• Study Type: interventional
• Target: 1,553
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism; Hypercalcemia; Parathyroid Neoplasm; Multiple Endocrine Neoplasia; MEN1

Keywords

Hypoglycemia; Genetics; Hyperparathyroidism

Outcome Measures

Primary Outcomes (3)

• 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: 1. 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. 2. Other familial: Non-MEN1 patients who had a positive family history of hyperparathyroidism suspicious for underlying germline predisposition syndrome. 3. Sporadic: Patients who did not have a positive family history of hyperparathyroidism. 4. Unknown: No data to help categorize the patients in any of the above categories.

  First year

• Organs With Identified Lesions

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

  Days 1-6

• Number of Lesions Identified

  The total number of lesions identified by each imaging modality

  Days 1-6

Study Arms (2)

Primary hyperparathyroidism

NO INTERVENTION

Patients with confirmed or suspected primary hyperparathyroidism or complications

DOTATATE and F-DOPA

EXPERIMENTAL

Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA

Drug: 68Ga-Dotatate; Drug: 18F-DOPA

Interventions

68Ga-Dotatate DRUG

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.

DOTATATE and F-DOPA

18F-DOPA DRUG

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.

DOTATATE and F-DOPA

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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..

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hyperparathyroidism; Hypercalcemia; Parathyroid Neoplasms; Multiple Endocrine Neoplasia; Hypoglycemia

Interventions

gallium Ga 68 dotatate; fluorodopa F 18

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glucose Metabolism Disorders

Results Point of Contact

• Title: Dr. Smita Jha
• Organization: NIDDK

smita.jha@nih.gov

301-827-1930

Study Officials

• Smita Jha, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: December 15, 1993
• Primary Completion: March 11, 2020
• Study Completion: December 23, 2020
• Last Updated: June 7, 2022
• Results First Posted: June 7, 2022

Record last verified: 2022-02-07

Locations

US (1)