Clinical Value of 18F-FCH PET in Localizing Parathyroid Lesions: Comparison With MIBI Scan. (parathyroid)

Clinical Value of 18F -Fluorocholine (18F-FCH) PET in Localizing Parathyroid Lesions: Comparison With 99mTc-sestamibi (MIBI) Scan.

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.

Study Overview

• Status: Completed
• Conditions: Parathyroid Diseases
• Intervention / Treatment: Drug: 18F-choline PET

Detailed Description

Hyperparathyroidism is a common endocrine disorder. Primary hyperparathyroidism is due to over-secretion of parathyroid hormone and subsequently hypercalcemia, phyophosphatemia and osteoporosis, while secondary hyperparathyroidism is due to physiological secretion of parathyroid hormone by the parathyroid glands in response to hypocalcemia. Surgical approach is the major treatment modality for majority of these patients with hyperparathyroidism. Pre-operative localization of hyperfunctioning glands may lead to minimally invasive surgery. The most commonly used imaging modality for this purpose is 99mTc-sestaMIBI, and supplemented by ultrasonography of the neck. However, the sensitivity and specificity is significantly lower in patients with multiple parathyroid lesions.

Recently, some investigators reported cases of parathyroid adenoma discovered incidentally on choline PET images performed for prostate cancer. 11C or 18F choline is a PET probe used in imaging prostate cancer and hepatocellular carcinoma. As a phospholipid analog, choline is integrated into newly synthesized membranes of proliferating cells by up-regulation of choline kinase. In addition, a previous study showed that the activity of phospholipid/Ca2+-dependent protein kinase was also higher in hyper-functioning parathyroid tissue than in atrophic parathyroid gland. Both mechanisms may be responsible for the uptake of choline tracers in hyperfunctioning parathyroid tissue. Up to now, there are only 3 original reports with limited patients using choline PET in the evaluation of hyperparathyroidism.

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;
2. evaluate the usefulness of 18F-FCH PET as a second-line tracer in MIBI scan negative patients.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-choline PET; PET/CT	Drug: 18F-choline PET; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: May 20, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: PET; SPECT; Hyperparathyroidism; 18F choline; Tc-99m sestaMIBI
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: 201411046MINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No