An interventional study of 18F-fluorocholine PET/CT in Hyperparathyroidism, sponsored by Buddhist Tzu Chi General Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Buddhist Tzu Chi General Hospital · Not applicable, Interventional, and Diagnostic
Hyperparathyroidism is a common endocrine disorder which can result in many severe complications. For patients with hyperparathyroidism, Tc-99m sestamibi imaging is the major imaging tool for pre-operative localization of the hyperfunctioning gland. However, sestamibi scan have only limited sensitivity in detecting multigland disease and hyperplastic foci. New imaging tracer with 18F-fluorocholine (18F-FCH) has showed avidity in parathyroid tissues. Nevertheless, the research data of 18F-FCH PET/CT are only preliminary.
The goal of our study is to compare the diagnostic performance of 18F-FCH PET/CT and single isotope dual phase sestamibi scintigraphy for patients with hyperparathyroidism.
From Jan. 1st, 2018 till Dec. 31st, 2019, the investigators will prospectively enroll patients with biochemical evidence of hyperparathyroidism and intended to receive pre-operative image study. The patients will receive single isotope dual phase sestamibi scintigraphy and 18F-FCH PET/CT. Each image will be evaluated by experienced interpreter for abnormal uptake suspicious for hyperfunctioning parathyroid gland. The reference standard will be the final surgical results. Diagnostic performance of both sestamibi scan and PET/CT scan will be measured and calculated.
The investigators conducted a prospective study to investigate the performance of 18F-choline (FCH) PET/CT and 99mTc- sestamibi scintigraphy in the pre-operative localization of hyperfunctioning parathyroid glands.
Single isotope dual phase Tc-99m sestamibi imaging protocol:
Fasting is not needed before radiotracer injection. No specific drug restriction is needed. Scan will be conduced by using a dual head gamma camera unit (Infinia Hawkeye; GE Medical Systems, Milwaukee,Wis), and scans will be interpreted on a work station with the use of compatible software (Xeleris).
An indwelling intravenous catheter connected to an infusion line and an saline syringe will be set on each patient. 99mTc-sestamibi (925 +/- 10% MBq) will be injected intravenously through the infusion line and will be flushed by saline. The image acquisition of the first phase is to be taken 15 minutes after radiotracer injection. The second phase will be acquired 2-4 hours after the initial tracer injection. The scintigraphic scan field will cover from neck to chest. Additional field-of-view will be performed if the patient has known surgically reimplanted parathyroid gland in the arms.
Two nuclear medicine physicians assess the single isotope dual phase 99mTc-sestamibi scintigraphy. The investigators have access to the patients' history and interpreted individually by each reader, with disagreements to be resolved by consensus. Uptake conspicuity will be evaluated in 4-graded scale. 0. Unable to identify any focal uptake; 1. Inconspicuous focus; 2. Focal mild uptake; 3. Focal intense uptake. For the determination of a diagnosis, score 0 and 1 are considered a negative resulte and 2 to 3 a positive result.
18F-FCH PET imaging protocol: Fasting is not needed before radiotracer injection. No specific drug restriction is needed. Scan will be conduced by using a PET/CT unit (Discovery ST; GE Medical Systems, Milwaukee,Wis), and scans will be interpreted on a work station with the use of compatible software (Xeleris).
An indwelling intravenous catheter connected to an infusion line and an saline syringe will be set on each patient. 18F-FCH (185 +/- 10% MBq) will be injected intravenously through the infusion line and will be flushed by saline. The injected 18F-FCH dose, injection time, post-injection residual activity, time of start imaging and time of end imaging will be recorded on case report form. 18F-FCH PET/CT scan acquisition is to be taken 5 to 10 minutes after radiotracer injection. The PET/CT (80-120 mA, 120 kVp) scan field will cover from skull to mid-thigh. Patient with reimplanted focus will be put into the field-of-view. The 18F-FCH PET/CT scan time will require 35-40 minutes.
Two nuclear medicine physicians assess the 18F-FCH PET/CT images. The investigators have access to the patients' history and interpreted individually by each reader, with disagreements to be resolved by consensus. However, the interpreters have no access to the sestamibi imaging results. For 18F-FCH PET/CT images, uptake conspicuity will be evaluated in 4-graded scale. 0. Unable to identify any focal uptake; 1. Inconspicuous focus; 2. Focal mild uptake; 3. Focal intense uptake. For the determination of a diagnosis, score 0 and 1 are considered a negative resulte and 2 to 3 a positive result.
Reference standard is established by surgical pathology:
The reference standard will be the surgical pathological results. Removed gland will be histologically confirmed as parathyroid adenoma or hyperplasia. For in situ hyperfunctioning parathyroid glands, the image results will be compared with the surgical results as correct lateralization (right side or left side), and correct polarity (upper pole or lower pole), sequentially. For ectopic and reimplanted glands, presence of pathological or biochemical evidence of hyperfunctioning gland removal of the image suggested lesion will be the reference standard.
309 studies on the registry are indexed under Hyperparathyroidism; 23 are open to participants now.
This study's enrollment of 38 is below the median of 55 across 205 interventional studies indexed under Hyperparathyroidism.
Browse Hyperparathyroidism studies →Buddhist Tzu Chi General Hospital is the lead sponsor of 88 studies on the registry; 20 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
18F-fluorocholine PET/CT
Diagnostic Test: 18F-fluorocholine PET/CT
Patients undergo both 18F-fluorocholine PET/CT and Single isotope dual phase Tc-99m sestamibi scan (both planar scan and SPECT/CT)
Also known as: Tc-99m sestamibi scintigraphy
The sensitivities of 18F-fluorocholine PET/CT and 99mTc sestamibi scan
The lesion-based sensitivities of these two image modalities using surgical pathology of the parathyroid gland as reference standard (The number of true positive image findings/The number of pathologically confirmed parathyroid adenoma or hyperplasia)
Time frame: 6 weeks
The specificities of 18F-fluorocholine PET/CT and 99mTc sestamibi scan
The lesion-based specificities of these two image modalities using surgical pathology of the parathyroid gland as reference standard (The number of true negative image findings/The number of negative finding on surgical pathology)
Time frame: 6 weeks
The accuracies of 18F-fluorocholine PET/CT and 99mTc sestamibi scan
The lesion-based accuracies of these two image modalities using surgical pathology of the parathyroid gland as reference standard (True positive and true negative image findings/The number of all surgical specimens)
Time frame: 6 weeks
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Buddhist Tzu Chi General Hospital