Medical imaging using radioactive pharmaceuticals to localize abnormal parathyroid glands in patients with negative convenctional imaging, as a necessary condition for planning an optimal surgical treatment

18F-fluorocholine PET/CT in primary hyperparathyroidism with negative preoperative localization - PET/CT in hyperparathyroidism

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002729-31-ES

Enrollment

Registered

2019-12-02

Start date

2020-03-02

Completion date

Unknown

Last updated

2020-03-11

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

Conditions

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

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: FLUOROMETILCOLINA (18F) Other descriptive name: FLUOROCHOLINE (18F) CHLORIDE Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with primary hyperparathyroidism Eligible for parathyroid surgery Negative, inconclusive or discordant preoperative imaging (both parathyroid scintigraphy and cervical ultrasound), performed within 6 months before PET-CT scan with 18F-Fluorocholine 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Patients with familial isolated primary hyperparathyroidism Patients with multiple endocrine neoplasia (MEN) Patients with secondary or terciary hyperparathyroidism Patients with suspected thyroid or parathyroid cancer

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the usefulness of PET-CT with 18F-Fluorocholine for preoperative localization of hyperfunctioning parathyroid glands in patients with primary hyperparathyroidism and negative conventional imaging (parathyroid scintigraphy and cervical ultrasound); Secondary Objective: To investigate the correlation between SUVmax and clinical, analytical and pathological parameters. To perform a cost-effectiveness analysis ;Primary end point(s): Surgical resection of the hyperfunctioning parathyroid glands detected by PET-CT scan with 18F-Fluorocholine;Timepoint(s) of evaluation of this end point: Surgery must be performed within 3 months after the PET-CT scan	—

Measure

Time frame

Main Objective: To evaluate the usefulness of PET-CT with 18F-Fluorocholine for preoperative localization of hyperfunctioning parathyroid glands in patients with primary hyperparathyroidism and negative conventional imaging (parathyroid scintigraphy and cervical ultrasound); Secondary Objective: To investigate the correlation between SUVmax and clinical, analytical and pathological parameters. To perform a cost-effectiveness analysis ;Primary end point(s): Surgical resection of the hyperfunctioning parathyroid glands detected by PET-CT scan with 18F-Fluorocholine;Timepoint(s) of evaluation of this end point: Surgery must be performed within 3 months after the PET-CT scan

—

Secondary

Measure	Time frame
Secondary end point(s): Percentage of cured patients after surgery;Timepoint(s) of evaluation of this end point: 3 months after surgery	—

Countries

Spain

Contacts

Public ContactFINBA

Fundación para la Investigación y la Innovación Biosanitaria del Principado de Asturias (FINBA)

elena.cienfuegosjovellanos_ccc@finba.es+34985652521

Outcome results

None listed

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