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Hyperparathyroidism, Primary clinical trials

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NCT ID: NCT05022641 Recruiting - Clinical trials for Primary Hyperparathyroidism

Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

NCT ID: NCT04969926 Recruiting - Clinical trials for Primary Hyperparathyroidism

Natural History Study of Parathyroid Disorders

Start date: November 30, 2021
Phase:
Study type: Observational

Background: Parathyroid disorders are very common in the general population and include disorders of parathyroid excess, deficiency, or defects in parathyroid hormone (PTH) signaling. PTH, the main secretory product of parathyroid glands is responsible for regulation of calcium-phosphate homeostasis. Objective: i) To investigate the cause of parathyroid disorders ii) To describe evolution, natural history, and longitudinal trends of parathyroid and related disorders seen in syndromic presentations like multiple endocrine neoplasia, hyperparathyroidism-jaw tumor syndrome Eligibility: People ages 6 months older who have, are at risk of having, or are related to a person with a parathyroid or related disorder. Design: Participants will be screened with a review of their medical records. Participants will be seen, tested, and treated by doctors based on their condition. Their visits may be in person or via telehealth. Participants will complete questionnaires. They will answer questions about their physical, mental, and social health. Participants may give samples such as saliva, blood, urine, or stool. Participants may give cheek cell samples. They will do this using a cheek swab or by spitting into a cup. Adult participants may give a skin biopsy. For this, a small bit of skin is removed with a punch tool. Participants may have medical photos taken. If participants have surgery during the course of their regular care either at the NIH or at a different hospital or doctor s office, researchers will ask for some of the leftover tissue. Participants will be in the study as long as they are being seen by their doctor.

NCT ID: NCT04948671 Recruiting - Clinical trials for Hyperparathyroidism, Primary

Primary Hyperparathyroidism and Gut Microbiota

HYPOGEUM
Start date: November 17, 2021
Phase:
Study type: Observational

Primary hyperparathyroidism (PHPT) may induce bone loss according with the composition of the gut microbiota (GM), and particularly, on the presence of intestinal bacterial that induce T helper 17 differentiation. We will evaluate GM composition and evaluate how GM modulates immune system in patients affected by PHPT with or without skeletal involvement. Furthermore, we will unravel the causal relationship between GM composition and T cells activation. Upon success, HYPOGEUM will show that GM sequencing is a screening tool to identify PHPT that will lose bone, suggesting novel strategies with antimicrobial treatments to prevent bone loss. HYPOGEUM will yield essential data to understand and prevent skeletal complications associated with PHPT.

NCT ID: NCT04895631 Recruiting - Clinical trials for Hyperparathyroidism, Primary

18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas

Start date: June 30, 2021
Phase: Phase 3
Study type: Interventional

This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.

NCT ID: NCT04844164 Completed - Clinical trials for Diabetes Mellitus, Type 1

Vitamin D Metabolism in Patients With Endocrine Disorders

Start date: April 16, 2019
Phase: Phase 1
Study type: Interventional

This prospective controlled interventional study aims to reveal the diversity of vitamin D metabolism in patients with certain endocrine disorders (Cushing's disease, acromegaly, primary hyperparathyroidism, diabetes mellitus type 1) compared to healthy adults. All patients will receive a single dose (150,000 IU) of cholecalciferol aqueous solution orally. Laboratory assessments including serum vitamin D metabolites (25(OH)D3, 25(OH)D2, 1,25(OH)2D3, 3-epi-25(OH)D3, 24,25(OH)2D3 and D3), free 25(OH)D, vitamin D-binding protein (DBP) and parathyroid hormone (PTH) as well as serum and urine biochemical parameters will be performed before the intake and on Days 1, 3 and 7 after the administration.

NCT ID: NCT04798092 Recruiting - Clinical trials for Primary Hyperparathyroidism

Impact of Parathyroidectomy on Renal Function

PARA-REIN
Start date: January 1, 2010
Phase:
Study type: Observational

Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.

NCT ID: NCT04740502 Completed - Clinical trials for Primary Hyperparathyroidism

Surgical Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies

Start date: January 1, 2008
Phase: N/A
Study type: Interventional

Although some surgeons still consider bilateral neck exploration as the best approach for primary hyperparathyroidism, nowadays most of them perceive the mini-invasive parathyroidectomy (MIP) as the best option for patients with concordant preoperative studies. Nevertheless, the consensus is heterogeneous for patients with unclear localisation studies, with some surgeons deeming BNE as mandatory and others suggesting that a mini-invasive approach is still possible if combined with IOPTH monitoring. In our research, we focused on patients with unclear preoperative localisation studies, to better understand the factors that can determine discordant or negative results between US and MIBI scan, in order to choose the best surgical approach and to evaluate the outcomes in this kind of patients.

NCT ID: NCT04608253 Completed - Clinical trials for Primary Hyperparathyroidism

A Retrospective Analysis of the Diagnostic Performance of 11C-choline PET/CT in Primary Hyperparathyroidism

Start date: January 1, 2015
Phase:
Study type: Observational

The leading cause of primary hyperparathyroidism (pHPT) is a solitary adenoma (89%). The treatment of pHPT is generally surgical removal of the overactive parathyroid gland(s). Since a solitary adenoma is the predominant cause, parathyroid surgery is preferably performed through a minimally invasive parathyroidectomy (MIP) in which only the suspected adenoma causing the pHPT is resected in a focused manner. To facilitate the performance of a MIP, accurate preoperative imaging is pivotal. This study aimed to analyze the diagnostic performance of 11C-choline PET/CT after prior negative or discordant first-line imaging in patients with pHPT undergoing parathyroid surgery with an optimized imaging protocol.

NCT ID: NCT04344886 Completed - Clinical trials for Primary Hyperparathyroidism

Optimization and Individualization of Diagnostic Scintigraphy Protocol and Minimally Invasive Radio-guided Parathyroid Surgery

Start date: May 1, 2016
Phase: N/A
Study type: Interventional

The radio-guided technique offers both help with in-vivo identification and ex-vivo confirmation of parathyroid adenoma. In-vivo accuracy is most important but its results are not satisfactory. The aim of this study was to evaluate if there is a beneficial effect of individualized timing of surgery using preoperative multi-phase 99mTc-MIBI single-photon emission computed tomography (SPECT)/CT on in-vivo characteristics of minimally invasive radio-guided parathyroidectomy.

NCT ID: NCT04305561 Completed - Clinical trials for Primary Hyperparathyroidism

Preoperative Localization Strategies in Primary Hyperparathyroidism

CEUS-project
Start date: September 5, 2019
Phase: N/A
Study type: Interventional

The purpose of this project is to examine, in a non-inferiority study, whether the combination of conventional ultrasound and contrast-enhanced ultrasound (CEUS) can replace the radiation-based imaging modalities that are currently used to localize pathological parathyroid glands prior to surgical removal in patients with primary hyperparathyroidism. This will take the form of a prospective paired cohort study where included patients receive a contrast-enhanced ultrasound examination in addition to the standard preoperative imaging regimen (subtraction scintigraphy with SPECT/CT and conventional ultrasound). Patients act as their own controls as all included patients undergo both CEUS and conventional imaging.