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

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ClinicalTrials.gov Identifier: NCT03555487
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment Phase
Parathyroid Diseases Drug: 18F-choline PET Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Value of 18F -Fluorocholine (18F-FCH) PET in Localizing Parathyroid Lesions: Comparison With 99mTc-sestamibi (MIBI) Scan.
Actual Study Start Date : May 5, 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. PET imaging [ Time Frame: in 3 days ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555487


Locations
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Taiwan
National Taiwan Univeristy Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yen Ruoh Fang, MD, PhD    886223123456 ext 65581    rfyen@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03555487     History of Changes
Other Study ID Numbers: 201411046MINB
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
Hyperparathyroidism
18F choline
PET
Tc-99m sestaMIBI
SPECT

Additional relevant MeSH terms:
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Parathyroid Diseases
Endocrine System Diseases
Parathyroid Hormone
Choline
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents