Clinical Value of 18F-FCH PET in Localizing Parathyroid Lesions: Comparison With MIBI Scan. (parathyroid)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03555487|
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: 18F-choline PET
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.
- 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.
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
|National Taiwan Univeristy Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Yen Ruoh Fang, MD, PhD 886223123456 ext 65581 email@example.com|