Completed

Studies of Hyperparathyroidism and Related Disorders

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What is being tested

68Ga-Dotatate

+ 18F-DOPA

Drug
Who is being recruted

Calcium Metabolism Disorders+17

+ Endocrine System Diseases

+ Endocrine Gland Neoplasms

Over 2 Months
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: December 1993
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: June 7, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: December 15, 1993

Actual date on which the first participant was enrolled.

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.

NCT00001277
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: June 7, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1553 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 2 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Calcium Metabolism DisordersEndocrine System DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsMetabolic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by SiteNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryNutritional and Metabolic DiseasesParathyroid DiseasesWater-Electrolyte ImbalanceGenetic Diseases, InbornGlucose Metabolism DisordersHypercalcemiaHyperparathyroidismHypoglycemiaMultiple Endocrine NeoplasiaParathyroid Neoplasms

Criteria

2 inclusion criteria required to participate
For females: Negative urine pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy
Patients who have genetically confirmed MEN1 or clinical criteria of MEN1
5 exclusion criteria prevent from participating
Patients that have recognized concurrent active infection
Patients unable or unwilling to give informed consent
Patients with known hypersensitivity to carbidopa, or who are concurrently taking a nonselective monoamine oxidase (MAO) inhibitor
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
Patients with confirmed or suspected primary hyperparathyroidism or complications

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center