Comparison of two nuclear imaging procedures - Tc-99m MIBI scintigraphy and F-18 Choline PET/CT - in patients with elevated parathyroid hormone and calcium blood levels due to a benign enlargement of a parathyroid gland

Comparison of the detection of parathyroid adenoms using Tc-99m MIBI scintigraphy and F-18 Choline PET/CT in patients with primary hyperparathyroidism

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000411-40-AT

Enrollment

Registered

2015-09-21

Start date

2015-10-23

Completion date

Unknown

Last updated

2026-02-16

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

Conditions

Primary hyperparathyroidism due to parathyroid adenoma

Interventions

Trade Name: IASOcholine Product Name: IASOcholine Pharmaceutical Form: Solution for injection INN or Proposed INN: N-((18F)Fluormethyl)-2-hydroxy-N,N-dimethylethanaminiumchlorid Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with primary hyperparathyreoidism (elevated blood levels of parathyroid hormone and calcium) Patients aged 18 - 85 years Written informed consent of the patient 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 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26

Exclusion criteria

Exclusion criteria: Age below 18 years (Minors) limited contractual capability Pregnancy or lactation Patients with a secondary or tertiary hyperparathyreoidism Patients with conservative management (no operative excision of the parathyroid gland planned)

Design outcomes

Primary

Measure	Time frame
Main Objective: In clinical routine, imaging with Tc-99m MIBI scintigraphy is used to diagnose parathyroid adenomas in patients with primary hyperparathyreoidism. However, F-18 Choline PET/CT seems to be more sensitive in the diagnosis of parathyroid adenomas. Main objective of the trial is the comparison of Tc-99m MIBI scintigraphy and F-18 Choline PET/CT in the diagnosis and localization of parathyroid adenomas, with the primary hypothesis, that F-18 Cholin PET/CT has a higher sensitivity for localization of parathyroid adenomas than Tc-99m MIBI scintigraphy.;Secondary Objective: Specificity of the detection of parathyroid adenomas comparing F-18 Choline PET/CT and Tc-99m MIBI scintigraphy;Primary end point(s): Inclusion of 52 patients (who underwent both F-18 Choline PET/CT and Tc-99m MIBI scintigraphy and histopathological confirmation of parathyroid adenoma after surgery) ;Timepoint(s) of evaluation of this end point: evaluation after parathyroid surgery	—

Measure

Time frame

Main Objective: In clinical routine, imaging with Tc-99m MIBI scintigraphy is used to diagnose parathyroid adenomas in patients with primary hyperparathyreoidism. However, F-18 Choline PET/CT seems to be more sensitive in the diagnosis of parathyroid adenomas. Main objective of the trial is the comparison of Tc-99m MIBI scintigraphy and F-18 Choline PET/CT in the diagnosis and localization of parathyroid adenomas, with the primary hypothesis, that F-18 Cholin PET/CT has a higher sensitivity for localization of parathyroid adenomas than Tc-99m MIBI scintigraphy.;Secondary Objective: Specificity of the detection of parathyroid adenomas comparing F-18 Choline PET/CT and Tc-99m MIBI scintigraphy;Primary end point(s): Inclusion of 52 patients (who underwent both F-18 Choline PET/CT and Tc-99m MIBI scintigraphy and histopathological confirmation of parathyroid adenoma after surgery) ;Timepoint(s) of evaluation of this end point: evaluation after parathyroid surgery

—

Secondary

Measure	Time frame
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -	—

Countries

Austria

Contacts

Public ContactDr. Christian Pirich

Department of Nuclear Medicine and Endocrinology

004366244823500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 19, 2026