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

Pre- and Postoperative Imaging and Monitoring of Patients with Primary Hyperparathyroidism: Preoperative imaging in primary hyperparathyroidism using dual-isotope subtraction scintigraphy (SPECT/CT) and 11C-Choline PET/CT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000726-63-DK

Enrollment

200

Registered

2018-06-06

Start date

2018-06-14

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary hyperparathyroidism MedDRA version: 20.0 Level: LLT Classification code 10036693 Term: Primary hyperparathyroidism System Organ Class: 100000004860

Interventions

Product Name: 11C-Choline "Herlev" Injection fluid Product Code: 27415258713 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: 11C-Choline "Herlev" injection fluid CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. The surgical result (confirmed by perioperative PTH-measurements and postoperative pathology) will serve as the gold standard. ;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..	—

Measure

Time frame

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. The surgical result (confirmed by perioperative PTH-measurements and postoperative pathology) will serve as the gold standard. ;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..

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactClinical Trial Info, PhD student

Department of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital

heh-fysiologi@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026