MET-PET-study - A comparative study of Tc-99m- sestamibi SPECT/ldCT and C-11-L-Methionin PET/diagnostic CT and their ability to locate paratyroid adenomas preoperatively.

Phase 1

• Conditions: Preoperative localisation of hyperfunctioning parathyroid tissue in suspected primary hyperparathyroidism.; MedDRA version: 19.1Level: LLTClassification code 10036693Term: Primary hyperparathyroidismSystem Organ Class: 100000004860; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2013-004886-14-DK
• Lead Sponsor: Dep. Nuclear medicine, Odense university hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-27
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Men and women above the age of 18 years who are referred to our department for preoperative localisation of hyperfunctioning parathyroid tissue prior to operation for suspected primary hyperparathyroidism.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Suspected secondary and tertiary hyperparathyroidism.
Suspected Familiar hypocalciuria hypercalcemia.
Suspected Familiar Hyperparathyroidism.
Suspected multiple endocrine neoplasia (MEN)
Patients treated with Lithium and / or Mimpara
Pregnancy.
Known allergy to the tracers infused.
Known allergy to iodine containing contrast agents.
Persons 18 years or younger.
Former operation / radiotherapy towards the neck.
If the prathyroidscintigraphy is cancelled or there is more than a forthnight between the two examniations.
If the patient has undergone operation between the two examinations.
If the patient is not operated within 12 months after completing the two examinations.
Inhability - if the person does not speak and understand danish to a degree acceptable to participate or has cognitive problems that complicates active participation.
If there is no signed consent to participate or the concent has been withdrawn.

Study & Design

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