Imaging of parathyroid glands prior to surgical removal in patients with parathyroid disease.

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10036693Term: Primary hyperparathyroidismSystem Organ Class: 100000004860; Primary hyperparathyroidism; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-000726-63-DK
• Lead Sponsor: Department of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-06
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients diagnosed with primary hyperparathyroidism are eligible for inclusion when referred for dual-isotope subtraction scintigraphy and parathyroidectomy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1) The patient does not wish to participate
2) The patient is unable to give informed consent
3) The patient is <18 years old
4) The patient is unable to cooperate e.g. severe claustrophobia
5) Other reason for secondary osteoporosis (e.g. treatment with glucocorticoids)
6) Current pregnancy or breastfeeding
7) Known hypothyroidism
8) Known cancer (other than basal cell carcinoma)
9) Hypersensitivity to the reseaerch drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to assess whether the sensitivity and specificity of 11C-Choline PET/CT is comparable to dual-isotope subtraction scintigraphy (SPECT/CT) in the preoperative location of hyperfunctioning parathyroid glands;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the proportion of correct 11C-Choline PET/CT assessments compared to the proportion of correct dual isotope subtraction scintigraphy (SPECT/CT) assessments with regard to location of hyperfunctioning parathyroid tissue.<br>The surgical result (confirmed by perioperative PTH-measurements and postoperative pathology) will serve as the gold standard. <br>;Timepoint(s) of evaluation of this end point: Results will be evaluated after 60, 100 and 200 patients have undergone scintigraphy and PET/CT and possible parathyroidectomy where the removed tissue will be evaluated by a pathologist..

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable