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Studies of Elevated Parathyroid Activity

Primary Purpose

Hyperparathyroidism, Hypercalcemia, Parathyroid Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68Ga-Dotatate
18F-DOPA
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hyperparathyroidism focused on measuring Hypoglycemia, Genetics, Hyperparathyroidism

Eligibility Criteria

2 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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..

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Primary hyperparathyroidism

DOTATATE and F-DOPA

Arm Description

Patients with confirmed or suspected primary hyperparathyroidism or complications

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

Outcomes

Primary Outcome Measures

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: 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
For each organ, agreement between 68Ga-DOTATATE and 18F-DOPA
Number of Lesions Identified
The total number of lesions identified by each imaging modality

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
May 12, 2022
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00001277
Brief Title
Studies of Elevated Parathyroid Activity
Official Title
Studies of Hyperparathyroidism and Related Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 7, 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 1993 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
December 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Hypercalcemia, Parathyroid Neoplasm, Multiple Endocrine Neoplasia, MEN1
Keywords
Hypoglycemia, Genetics, Hyperparathyroidism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1553 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary hyperparathyroidism
Arm Type
No Intervention
Arm Description
Patients with confirmed or suspected primary hyperparathyroidism or complications
Arm Title
DOTATATE and F-DOPA
Arm Type
Experimental
Arm Description
Patients scanned using imaging agents 68GALLIUM-DOTATATE and 18F-DOPA
Intervention Type
Drug
Intervention Name(s)
68Ga-Dotatate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
18F-DOPA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Type of Hyperparathyroidism
Description
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.
Time Frame
First year
Title
Organs With Identified Lesions
Description
For each organ, agreement between 68Ga-DOTATATE and 18F-DOPA
Time Frame
Days 1-6
Title
Number of Lesions Identified
Description
The total number of lesions identified by each imaging modality
Time Frame
Days 1-6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
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..
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smita Jha, M.D.
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1991-DK-0085.html
Description
NIH Clinical Center Detailed Web Page

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Studies of Elevated Parathyroid Activity

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