18F-choline Positron-emission-tomography - Computed-tomography Compared to Conventional Imaging for Localizing Diseased Parathyroid Glands in Primary Hyperparathyroidism
18F-choline-PET-CT vs Ultrasonography and 99-technetium Sestamibi Scintigraphy in Preoperative Localization for pHPT - A Randomized Trial
1 other identifier
interventional
88
1 country
1
Brief Summary
The goal of this open, single-center, prospective, randomized, clinical study is to compare imaging with \[18F\]fluoromethyl-dimethyl-2-hydroxyethylammonium (18F-choline) positron-emission-tomography - computed-tomography, 18F-ch-PETCT, to conventional imaging with ultrasonography and sestamibi scintigraphy in localizing diseased parathyroid glands in patients diagnosed with primary hyperparathyroidism, pHPT. The question this study aims to answer is: can 18-F-ch-PET-CT more precisely localize diseased parathyroid glands in patients with pHPT before surgery? The objective of the study is to help improve precision in parathyroid surgery, thereby increasing cure rates, minimizing complications, and shortening operation times.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 17, 2025
CompletedFirst Posted
Study publicly available on registry
August 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
August 24, 2025
August 1, 2025
4 years
August 17, 2025
August 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Operation time
Operation time in minutes, skin-to-skin
During surgery
Study Arms (2)
18-F-choline-PET
EXPERIMENTALInvestigation with 18-F-choline-PET-CT
Conventional
ACTIVE COMPARATORConventional (standard) imaging with ultrasonography and sestamibi scintigraphy
Interventions
Eligibility Criteria
You may qualify if:
- Proven primary hyperparathyroidism Indication for surgery Adult (\>18 years)
You may not qualify if:
- Inability to give informed consent Allergy to contrast Pregnancy and breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
Skåne University Hospital
Lund, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
August 17, 2025
First Posted
August 24, 2025
Study Start
January 1, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
August 24, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Personal integrity.