Clinical Value of 18F-FCH PET in Localizing Parathyroid Lesions: Comparison With MIBI Scan. (parathyroid)
Primary Purpose
Parathyroid Diseases
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
18F-choline PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Parathyroid Diseases focused on measuring Hyperparathyroidism, 18F choline, PET, Tc-99m sestaMIBI, SPECT
Eligibility 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.
Sites / Locations
- National Taiwan Univeristy Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-choline PET
Arm Description
PET/CT
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03555487
First Posted
May 20, 2018
Last Updated
June 25, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03555487
Brief Title
Clinical Value of 18F-FCH PET in Localizing Parathyroid Lesions: Comparison With MIBI Scan.
Acronym
parathyroid
Official Title
Clinical Value of 18F -Fluorocholine (18F-FCH) PET in Localizing Parathyroid Lesions: Comparison With 99mTc-sestamibi (MIBI) Scan.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 5, 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parathyroid Diseases
Keywords
Hyperparathyroidism, 18F choline, PET, Tc-99m sestaMIBI, SPECT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
18F-choline PET
Arm Type
Experimental
Arm Description
PET/CT
Intervention Type
Drug
Intervention Name(s)
18F-choline PET
Intervention Description
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 Measure Information:
Title
PET imaging
Description
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.
Time Frame
in 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Taiwan Univeristy Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Value of 18F-FCH PET in Localizing Parathyroid Lesions: Comparison With MIBI Scan.
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