NCT03555487

Brief Summary

This prospective study aims to 1\. compare the detection rates among sonography, MIBI scan and 18F-FCH PET for localization of the parathyroid lesions including adenoma, hyperplasia or carcinoma; evaluate the usefulness of 18F-FCH PET as a second-line tracer in MIBI scan negative patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2018

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

3.1 years

First QC Date

May 20, 2018

Last Update Submit

June 25, 2019

Conditions

Parathyroid Diseases

Keywords

Hyperparathyroidism18F cholinePETTc-99m sestaMIBISPECT

Outcome Measures

Primary Outcomes (1)

  • PET imaging

    By visual interpretation if there are focal areas of abnormal 18F-FCH accumulation. The presence, number, size, character, and location of suspected lesions will be filed for each patient in this study.

    in 3 days

Study Arms (1)

18F-choline PET

EXPERIMENTAL

PET/CT

Drug: 18F-choline PET

Interventions

18F-choline PETDRUG

5mCi of 18F-FCH will be injected intravenously. PET imaging will be performed on PET/CT scanner. PET/CT from skull base to diaphragm will be started at 50 minutes after the injection.

18F-choline PET

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parahyperthyroidism (serum iPTH 65 pg / mL; normal range : 12-65), merged with normal or high serum calcium concentration (serum calcium 2.35 mmol / L; normal range: 2.15-2.58) and normal or low serum phosphate concentration (serum phosphorus 3.75 mg / dL; normal range : 2.5-5.0).
  • High serum calcium concentration (serum calcium 2.58 mmol/L), but the blood parathyroid hormone concentration in normal range (serum iPTH 12-65pg / mL), hyperthyroidism is suspected.
  • MIBI scan has been performed or arranged.
  • Age：above 20 years old.

You may not qualify if:

  • Patient with Familial hypocalciuric hypercalcemia：daily calcium excretion \< 100 mg/24h and fractional excretion of calcium \< 1%.
  • taking or was taking lithium.
  • vitamin D deficiency (25-OH vitamin D \< 10 ng/mL).
  • Patients with pregnancy or recently having a plan for pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Parathyroid DiseasesHyperparathyroidism

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2018

First Posted

June 13, 2018

Study Start

May 5, 2015

Primary Completion

June 1, 2018

Study Completion

October 1, 2018

Last Updated

June 26, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)