Primary HyperparathyroidismPhase 2NCT01783002
11C Methionine PET for the Detection of Hyperfunctional Parathyroid Tissues
A Phase 2 study testing 11C-Methionine PET/CT scanning, 18F-FDG PET/CT scanning and SPECT-CT scanning in people with Primary Hyperparathyroidism, run by University of British Columbia at 1 site in Canada.
Trial summary
The overall sensitivity and specificity of 11C-MET PET/CT is superior to 18F-FDG PET/CT and conventional SPECT-CT for the detection of abnormal parathyroid glands. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- 11C-Methionine PET/CT scanning, 18F-FDG PET/CT scanning and SPECT-CT scanning
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Jul 2018
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults > age 18;
- Able to provide written informed consent;
- Subjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism.
Who cannot join
- Subjects with previous successful parathyroidectomy and parathyroid tissue reimplantation;
- Pregnancy;
- Subjects who are unable to tolerate the physical/logistical requirements of completing two PET/CT scans, including lying still for a prolonged period of time and receiving two intravenous injections.
- Subjects who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT machine (diameter 70cm).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Hayley Corbett, 604-877-6000 ext. 2818, hayley.corbett@bccancer.bc.ca
Don Wilson, MD, FRCPC
About this study
Official title: Pre-operative Parathyroid Imaging: a Comparison of 11C-Methionine PET, 18F-FDG PET AND SPEC-CT for the Detection of Hyperfunctional Parathyroid Tissues
The overall sensitivity and specificity of 11C-MET PET/CT is superior to 18F-FDG PET/CT and conventional SPECT-CT for the detection of abnormal parathyroid glands.
Read the detailed description
STUDY OBJECTIVES Primary: To compare the accuracy, sensitivity and specificity of 11C-methionine (MET) PET/CT and 99mTc-MIBI SPECT-CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism.
Secondary:To compare the accuracy, sensitivity and specificity of 11C-MET and 18F-FDG PET/CT scans in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism.
STUDY DESIGN A phase II diagnostic imaging, single-centre study to compare the accuracy of 11C-MET PET/CT with standard 99mTc-MIBI SPECT-CT and with 18F-FDG PET/CT imaging in patients with primary hyperparathyroidism.
STUDY POPULATION Number of Subjects: 50 patients Number of groups: 1: 50 with primary hyperparathyroidism. Age/Gender: Age greater than or equal to 19 years / Male and Female Study specific requirements: Subjects with clinically suspected primary hyperparathyroidism who require 99mTc-MIBI SPECT-CT parathyroid imaging.
INVESTIGATIONAL PRODUCT Product: 11C-Methionine Route of administration: Intravenous Dosage(s) and frequency: Radioactive dose of 11C-Methionine of 6 MBq per kilogram body weight per injection (maximum dose of 555 MBq); one injection per patient.
COMPARATOR PRODUCTS Product: 99mTc-Methoxyisobutylisonitrite; 18F-Fluorodeoxyglucose Route of administration: Intravenous Dosage(s) and frequency: (1) Radioactive dose of 99mTc-Methoxyisobutylisonitrite of 555 - 740 MBq per injection; one injection per patient. (2) Radioactive dose of 18F-Fluorodeoxyglucose of 296 - 521 MBq per injection; one injection per patient.
EVALUATION CRITERIA Efficacy: The comparison of the accuracy, sensitivity, and specificity of 11C-MET PET/CT with 99mTc-MIBI SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism.
Safety: Vital signs before and following 11C-MET administration; adverse events collection.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- 11C-Methionine PET/CT scanning, 18F-FDG PET/CT scanning, SPECT-CT scanning
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-Methionine PET/CT scanningRadiation
Also called 11C-MET
PET with the radiopharmaceutical carbon-11 methionine (11C-MET) has been considered to improve diagnosis due to a superior spatial resolution and higher specificity compared to other radiotracers such as 18F-FDG. For the 11C-MET PET/CT, the patient will receive an intravenous bolus injection of 11C-MET as manufactured at the BCCA production facility at a dose of 6 (0.16 mCi) MBq per kilogram but not to exceed 555 MBq (15 mCi).
18F-FDG PET/CT scanningRadiation
For PET/CT scans, the patient will first receive an intravenous bolus injection of 18F-FDG as manufactured at the BCCA production facility in a dose determined by body weight but not to exceed 521 MBq (14.1 mCi). Our standard adult prescription (70kg adult) for 18F-FDG is 296 MBq (8.0 mCi). The target dose for body scans is increased by 59.2 MBq (1.6 mCi) for every 20 kg increase in body weight to a maximum target dose of 474 MBq (12.8 mCi).
SPECT-CT scanningRadiation
For the SPECT-CT scan, each injection of intravenous 99mTc-MIBI is dosed at a maximum of 20 mCi (740MBq), as per usual standard of care. The energy window of each scan is at 140 keV, consistent with the standard of SPEC-CT imaging techniques.
| Study group | Role | What they receive |
|---|---|---|
| Primary hyperparathyroidism | Experimental | Subjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism. All patients will undergo 11C-methionine PET/CT, SPECT-CT and 18F-FDG PET/CT scanning. Receives: Radiation: 11C-Methionine PET/CT scanning; Radiation: 18F-FDG PET/CT scanning; Radiation: SPECT-CT scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the sensitivity of 11C-MET PET/CT, SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism
Sensitivity is the percentage of patients that were correctly identified to have an abnormal parathyroid gland by the imaging studies.
Measured: Patient will undergo the scans at baseline
To compare the specificity of11C-MET PET/CT, SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism
Specificity is defined as the percentage of patients that were correctly rejected for having an abnormal parathyroid gland by the imaging studies.
Measured: Patient will undergo the scans at baseline
Secondary outcomes (1)
To evaluate the safety profile of 11C-MET PET/CT.
All adverse events will be recorded. An Adverse Event (AE) is any untoward, undesired, unplanned medical occurrence in a participant and does not necessarily have a causal relationship with the study intervention. Expected adverse events from PET/CT scans include bruising, bleeding or infection at the site of intravenous radiotracer injection. Other expected adverse events include feeling of discomfort or claustrophobia from being in the scanner.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startMay 2014
- Primary completionMar 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Responsible party
- Sponsor
- Investigators
- Donald W Anderson, MD, FRCSC, Principal investigator, University of British Columbia; Vancouver General HospitalDon Wilson, MD, FRCPC, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783002
- Sponsor's protocol ID
- H12-01220
- Status last verified
- Sep 2015
- First submitted
- 4 Jan 2013
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Parathyroid Imaging: a Comparison of 11C-Methionine PET, 18F-FDG PET AND SPEC-CT for the Detection of Hyperfunctional Parathyroid Tissues
- ClinicalTrials.gov ID
- NCT01783002
- Acronym / sponsor ID
- H12-01220
- Conditions
- Primary Hyperparathyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Study start
- May 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 4 Feb 2013 (estimated)
- 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.
The overall sensitivity and specificity of 11C-MET PET/CT is superior to 18F-FDG PET/CT and conventional SPECT-CT for the detection of abnormal parathyroid glands.
Detailed description
STUDY OBJECTIVES Primary: To compare the accuracy, sensitivity and specificity of 11C-methionine (MET) PET/CT and 99mTc-MIBI SPECT-CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism.
Secondary:To compare the accuracy, sensitivity and specificity of 11C-MET and 18F-FDG PET/CT scans in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism.
STUDY DESIGN A phase II diagnostic imaging, single-centre study to compare the accuracy of 11C-MET PET/CT with standard 99mTc-MIBI SPECT-CT and with 18F-FDG PET/CT imaging in patients with primary hyperparathyroidism.
STUDY POPULATION Number of Subjects: 50 patients Number of groups: 1: 50 with primary hyperparathyroidism. Age/Gender: Age greater than or equal to 19 years / Male and Female Study specific requirements: Subjects with clinically suspected primary hyperparathyroidism who require 99mTc-MIBI SPECT-CT parathyroid imaging.
INVESTIGATIONAL PRODUCT Product: 11C-Methionine Route of administration: Intravenous Dosage(s) and frequency: Radioactive dose of 11C-Methionine of 6 MBq per kilogram body weight per injection (maximum dose of 555 MBq); one injection per patient.
COMPARATOR PRODUCTS Product: 99mTc-Methoxyisobutylisonitrite; 18F-Fluorodeoxyglucose Route of administration: Intravenous Dosage(s) and frequency: (1) Radioactive dose of 99mTc-Methoxyisobutylisonitrite of 555 - 740 MBq per injection; one injection per patient. (2) Radioactive dose of 18F-Fluorodeoxyglucose of 296 - 521 MBq per injection; one injection per patient.
EVALUATION CRITERIA Efficacy: The comparison of the accuracy, sensitivity, and specificity of 11C-MET PET/CT with 99mTc-MIBI SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism.
Safety: Vital signs before and following 11C-MET administration; adverse events collection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary hyperparathyroidism | Experimental | Radiation: 11C-Methionine PET/CT scanning, Radiation: 18F-FDG PET/CT scanning, Radiation: SPECT-CT scanningSubjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism. All patients will undergo 11C-methionine PET/CT, SPECT-CT and 18F-FDG PET/CT scanning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults > age 18;
- Able to provide written informed consent;
- Subjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism.
Key exclusion criteria (4 listed)
- Subjects with previous successful parathyroidectomy and parathyroid tissue reimplantation;
- Pregnancy;
- Subjects who are unable to tolerate the physical/logistical requirements of completing two PET/CT scans, including lying still for a prolonged period of time and receiving two intravenous injections.
- Subjects who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT machine (diameter 70cm).
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 |
|---|---|---|
| 11C-Methionine PET/CT scanningAlso: 11C-METPET with the radiopharmaceutical carbon-11 methionine (11C-MET) has been considered to improve diagnosis due to a superior spatial resolution and higher specificity compared to other radiotracers such as 18F-FDG. For the 11C-MET PET/CT, the patient will receive an intravenous bolus injection of 11C-MET as manufactured at the BCCA production facility at a dose of 6 (0.16 mCi) MBq per kilogram but not to exceed 555 MBq (15 mCi). | Radiation | Primary hyperparathyroidism |
| 18F-FDG PET/CT scanningFor PET/CT scans, the patient will first receive an intravenous bolus injection of 18F-FDG as manufactured at the BCCA production facility in a dose determined by body weight but not to exceed 521 MBq (14.1 mCi). Our standard adult prescription (70kg adult) for 18F-FDG is 296 MBq (8.0 mCi). The target dose for body scans is increased by 59.2 MBq (1.6 mCi) for every 20 kg increase in body weight to a maximum target dose of 474 MBq (12.8 mCi). | Radiation | Primary hyperparathyroidism |
| SPECT-CT scanningFor the SPECT-CT scan, each injection of intravenous 99mTc-MIBI is dosed at a maximum of 20 mCi (740MBq), as per usual standard of care. The energy window of each scan is at 140 keV, consistent with the standard of SPEC-CT imaging techniques. | Radiation | Primary hyperparathyroidism |
Primary outcome
To compare the sensitivity of 11C-MET PET/CT, SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism
Time frame: Patient will undergo the scans at baseline
Sensitivity is the percentage of patients that were correctly identified to have an abnormal parathyroid gland by the imaging studies.
To compare the specificity of11C-MET PET/CT, SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism
Time frame: Patient will undergo the scans at baseline
Specificity is defined as the percentage of patients that were correctly rejected for having an abnormal parathyroid gland by the imaging studies.
1 secondary outcome
To evaluate the safety profile of 11C-MET PET/CT.
Time frame: Up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2015.
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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.
Donald W Anderson, MD, FRCSC principal investigator
University of British Columbia; Vancouver General Hospital
Don Wilson, MD, FRCPC principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 11C-Methionine PET/CT scanning, 18F-FDG PET/CT scanning and SPECT-CT scanning in people with Primary Hyperparathyroidism, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Sep 2015. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hayley Corbett (604-877-6000 ext. 2818, hayley.corbett@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the sensitivity of 11C-MET PET/CT, SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism (time frame: Patient will undergo the scans at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2015.