HyperparathyroidismNCT04316845
18F-fluorocholine PET/CT for Hyperparathyroidism
A study testing 18F-fluorocholine PET/CT in people with Hyperparathyroidism, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- 18F-fluorocholine PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jan 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are diagnosed to have hyperparathyroidism based on serum iPTH data (> 72 pg/mL).
- Planned to undergo surgical resection of the hyperfunctioning parathyroid gland.
- Referred for single isotope dual phase Tc-99m sestamibi scintigraphy.
- The 18F-FCH PET is performed within 6 weeks of the single isotope dual phase Tc-99m sestamibi scintigraphy.
- If premenopausal and sexually active woman, need contraception (tubal ligation, intrauterine devices, or oral contracepts/condom after the last menstrual period till the image exams)
Who cannot join
- Surgical management is not considered.
- Younger than 20-year-old.
- Factors that hampers the patient to receive positron emission tomography, e.g., unstable vital signs (shock), conscious disturbance, claustrophobia, etc...
- Allergic to investigaional drug.
- Pregnant or lactating woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 18F-Fluorocholine PET/CT in the Pre-operative Localization of Hyperfunctional Parathyroid Gland in Primary and Secondary Hyperparathyroidism
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.
Read the detailed description
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.
- Conditions
- Hyperparathyroidism
- Being tested
- 18F-fluorocholine PET/CT
- Keywords
- Hyperparathyroidism, sestamibi, scintigraphy, 18F-Fluorocholine, PET
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluorocholine PET/CTDiagnostic test
Also called Tc-99m sestamibi scintigraphy
Patients undergo both 18F-fluorocholine PET/CT and Single isotope dual phase Tc-99m sestamibi scan (both planar scan and SPECT/CT)
| Study group | Role | What they receive |
|---|---|---|
| 18F-fluorocholine PET/CT | Experimental | 18F-fluorocholine PET/CT Receives: Diagnostic Test: 18F-fluorocholine PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start16 Jan 2018
- Primary completion6 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient undergoes both 18F-fluorocholine PET/CT and sestamibi scan
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Hsin Liu, M.D., Principal investigator, Hualien Tzu Chi Hospital, Buddhist Tzu ChiMedical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316845
- Sponsor's protocol ID
- IRB106-74-A
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen YH, Chen HT, Lee MC, Liu SH, Wang LY, Lue KH, Chan SC. Preoperative F-18 fluorocholine PET/CT for the detection of hyperfunctioning parathyroid glands in patients with secondary or tertiary hyperparathyroidism: comparison with Tc-99m sestamibi scan and neck ultrasound. Ann Nucl Med. 2020 Aug;34(8):527-537. doi: 10.1007/s12149-020-01479-2. Epub 2020 May 20.
PubMed 32436180
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluorocholine PET/CT in the Pre-operative Localization of Hyperfunctional Parathyroid Gland in Primary and Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT04316845
- Acronym / sponsor ID
- IRB106-74-A
- Conditions
- Hyperparathyroidism
- Keywords
- Hyperparathyroidism, sestamibi, scintigraphy, 18F-Fluorocholine, PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient undergoes both 18F-fluorocholine PET/CT and sestamibi scan
| Arm | Type | Receives |
|---|---|---|
| 18F-fluorocholine PET/CT | Experimental | Diagnostic Test: 18F-fluorocholine PET/CT18F-fluorocholine PET/CT |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients are diagnosed to have hyperparathyroidism based on serum iPTH data (> 72 pg/mL).
- Planned to undergo surgical resection of the hyperfunctioning parathyroid gland.
- Referred for single isotope dual phase Tc-99m sestamibi scintigraphy.
- The 18F-FCH PET is performed within 6 weeks of the single isotope dual phase Tc-99m sestamibi scintigraphy.
- If premenopausal and sexually active woman, need contraception (tubal ligation, intrauterine devices, or oral contracepts/condom after the last menstrual period till the image exams)
Key exclusion criteria (5 listed)
- Surgical management is not considered.
- Younger than 20-year-old.
- Factors that hampers the patient to receive positron emission tomography, e.g., unstable vital signs (shock), conscious disturbance, claustrophobia, etc...
- Allergic to investigaional drug.
- Pregnant or lactating woman.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-fluorocholine PET/CTAlso: Tc-99m sestamibi scintigraphyPatients undergo both 18F-fluorocholine PET/CT and Single isotope dual phase Tc-99m sestamibi scan (both planar scan and SPECT/CT) | Diagnostic test | 18F-fluorocholine PET/CT |
Primary outcome
The sensitivities of 18F-fluorocholine PET/CT and 99mTc sestamibi scan
Time frame: 6 weeks
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)
The specificities of 18F-fluorocholine PET/CT and 99mTc sestamibi scan
Time frame: 6 weeks
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)
The accuracies of 18F-fluorocholine PET/CT and 99mTc sestamibi scan
Time frame: 6 weeks
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 32436180Chen YH, Chen HT, Lee MC, Liu SH, Wang LY, Lue KH, Chan SC. Preoperative F-18 fluorocholine PET/CT for the detection of hyperfunctioning parathyroid glands in patients with secondary or tertiary hyperparathyroidism: comparison with Tc-99m sestamibi scan and neck ultrasound. Ann Nucl Med. 2020 Aug;34(8):527-537. doi: 10.1007/s12149-020-01479-2. Epub 2020 May 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Hsin Liu, M.D. principal investigator
Hualien Tzu Chi Hospital, Buddhist Tzu ChiMedical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-fluorocholine PET/CT in people with Hyperparathyroidism, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivities of 18F-fluorocholine PET/CT and 99mTc sestamibi scan (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.