Cardiac SarcoidosisNCT01764191
18F-FDG PET Imaging in Cardiac Sarcoidosis
A study testing 18F-Fluorodeoxyglucose (18F-FDG) PET/CT in people with Cardiac Sarcoidosis, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
This study has been designed to provide patients suspected of having cardiac sarcoidosis (CS) with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with currently available methods, therefore this project will allow access to 18F FDG PET/CT scanning, which may more accurately diagnose the presence… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Sarcoidosis
- What is being tested?
- 18F-Fluorodeoxyglucose (18F-FDG) PET/CT
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 19 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Age 19 years or older.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 - 3.
- Able to provide written informed consent.
- Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 45 minutes and tolerating intravenous cannulation for injection.
- Clinical suspicion of cardiac sarcoidosis, including a combination of:
- Patients with systemic sarcoidosis and symptoms suggestive of heart failure (eg. fatigue, dyspnea, edema etc.)
Show all 17Show fewer
- Idiopathic heart failure, particularly of preserved systolic function variety
- Presentation with arrhythmia (eg. heart block, ventricular tachycardia, etc.)
- Progressive heart failure symptoms not responding to conventional therapy
- Other clinical presentations where in the experience of treating cardiologist cardiac sarcoid needs to be ruled out (ie. Heart transplant or ventricular assist device candidacy)
- Routine tests for CS are inconclusive, such as:
- ECG
- Holter
- echocardiogram
- 67Ga scintigraphy is inconclusive
- Cardiac MRI is inconclusive or not possible to conduct
- Patient has renal dysfunction which limits other radionuclide imaging.
Who cannot join
- Patients blood glucose > 11.1 mmol/L (200 mg/dL) measured by glucometer immediately prior to scan.
- Patients with confirmed diabetes.
- Patients unable to comply with the dietary modifications or prolonged fasting as per trial protocol.
- Pregnancy.
- Patients who are medically unstable eg. acute cardiac or respiratory distress, or hypotensive.
- Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT machine (diameter 70 cm).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: [18 F]-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET) in Cardiac Sarcoidosis
This study has been designed to provide patients suspected of having cardiac sarcoidosis (CS) with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with currently available methods, therefore this project will allow access to 18F FDG PET/CT scanning, which may more accurately diagnose the presence of CS. This study will also provide additional data to further examine the effectiveness and safety profile of 18F FDG for this condition. Accurate and early detection is important to allow for better management of CS and improve patient care.
The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety and effectiveness of 18F-FDG PET/CT in this patient population
Read the detailed description
- Purpose:The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety and effectiveness of 18F-FDG PET/CT in this patient population.
- Hypothesis:18F-FDG PET/CT has greater sensitivity, specificity, and accuracy compared to the current clinical gold standard of diagnosis for CS, the Japanese Ministry of Health, Labour, and Welfare (MHLW) guidelines
- Justification:Currently a clinical diagnosis CS is diagnosed using a combination of diagnostic techniques including imaging and biopsy. Biopsies are challenging as it can be difficult to locate the disease or access the desired biopsy location. MRI has been proven effective but it is limited as patients with pacemakers and cardioverter-defibrillators or patients with renal impairments are unable to have an MRI. Finally radionuclide scintigraphy with Gallium-67 or Thallium-201 (201Tl) has been useful, but can be non-specific for sarcoidosis. 18F-FDG PET/CT has significant advantages over other radionuclide imaging modalities due to superior resolution of PET coupled with the affinity of inflammatory cardiac tissue to metabolize FDG. 18F-FDG PET/CT has been found to have higher sensitivity and specificity over other conventionally used imaging modalities.
- Research Method:This will be an expanded access study in which adult subjects with a clinical suspicion of CS will be invited to participate, in order to identify potential sites for biopsy or provide confirmation of the presence of CS. Based on population extrapolation from all diagnosed or suspected cases of CS in British Columbia (BC), as well as expert clinical opinion, it is estimated that 10 to 15 patients per year will be enrolled in the study. Over a three year period, the expected sample size will be 30 - 45 patients. All subjects will receive an 18F-FDG PET/CT at the BC Cancer Agency (BCCA) - Vancouver Centre.
- Statistical Analysis:The planned sample size is 150 patients. The primary endpoint is to provide PET/CT imaging to patients diagnosed with or suspected of CS. The secondary end-point will be to assess the sensitivity, specificity and accuracy of 18F-FDG PET in BC population. Confidence intervals of 95% will be used to assess this using exact binomial distribution. All analyses will be performed in direct consultation with a qualified statistician.
Sensitivity (ratio of true positive lesions to total positive lesions), specificity (ratio of true negative lesions to total negative lesions) and accuracy (ratio of total correct studies to the total number of biopsied lesions) of 18F-FDG PET studies performed by the BCCA will be obtained by comparing results of the PET scan with a composite of the outcome of clinical examinations, histopathological diagnosis, if those results are available, and results of all other available imaging (cardiac MRI, 201Tl, 67Ga). Confidence intervals (95% CI) for sensitivity, specificity and accuracy will be calculated using exact binomial distribution.
- Conditions
- Cardiac Sarcoidosis
- Being tested
- 18F-Fluorodeoxyglucose (18F-FDG) PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluorodeoxyglucose (18F-FDG) PET/CTOther
All subjects suspected of cardiac sarcoidosis will receive an intravenous dose of 18F-FDG (determined by weight, but not to exceed 521 MBq). Following an uptake phase of about 60 minutes, each subject will receive a PET/CT scan to evaluate the presence of cardiac sarcoidosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764191
- Sponsor's protocol ID
- BCCA-Cardiac PET
- Status last verified
- Feb 2022
- First submitted
- 3 Jan 2013
- Last updated
- 4 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18 F]-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET) in Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT01764191
- Acronym / sponsor ID
- BCCA-Cardiac PET
- Conditions
- Cardiac Sarcoidosis
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- First posted
- 9 Jan 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.
This study has been designed to provide patients suspected of having cardiac sarcoidosis (CS) with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with currently available methods, therefore this project will allow access to 18F FDG PET/CT scanning, which may more accurately diagnose the presence of CS. This study will also provide additional data to further examine the effectiveness and safety profile of 18F FDG for this condition. Accurate and early detection is important to allow for better management of CS and improve patient care.
The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety and effectiveness of 18F-FDG PET/CT in this patient population
Detailed description
- Purpose:The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety and effectiveness of 18F-FDG PET/CT in this patient population.
- Hypothesis:18F-FDG PET/CT has greater sensitivity, specificity, and accuracy compared to the current clinical gold standard of diagnosis for CS, the Japanese Ministry of Health, Labour, and Welfare (MHLW) guidelines
- Justification:Currently a clinical diagnosis CS is diagnosed using a combination of diagnostic techniques including imaging and biopsy. Biopsies are challenging as it can be difficult to locate the disease or access the desired biopsy location. MRI has been proven effective but it is limited as patients with pacemakers and cardioverter-defibrillators or patients with renal impairments are unable to have an MRI. Finally radionuclide scintigraphy with Gallium-67 or Thallium-201 (201Tl) has been useful, but can be non-specific for sarcoidosis. 18F-FDG PET/CT has significant advantages over other radionuclide imaging modalities due to superior resolution of PET coupled with the affinity of inflammatory cardiac tissue to metabolize FDG. 18F-FDG PET/CT has been found to have higher sensitivity and specificity over other conventionally used imaging modalities.
- Research Method:This will be an expanded access study in which adult subjects with a clinical suspicion of CS will be invited to participate, in order to identify potential sites for biopsy or provide confirmation of the presence of CS. Based on population extrapolation from all diagnosed or suspected cases of CS in British Columbia (BC), as well as expert clinical opinion, it is estimated that 10 to 15 patients per year will be enrolled in the study. Over a three year period, the expected sample size will be 30 - 45 patients. All subjects will receive an 18F-FDG PET/CT at the BC Cancer Agency (BCCA) - Vancouver Centre.
- Statistical Analysis:The planned sample size is 150 patients. The primary endpoint is to provide PET/CT imaging to patients diagnosed with or suspected of CS. The secondary end-point will be to assess the sensitivity, specificity and accuracy of 18F-FDG PET in BC population. Confidence intervals of 95% will be used to assess this using exact binomial distribution. All analyses will be performed in direct consultation with a qualified statistician.
Sensitivity (ratio of true positive lesions to total positive lesions), specificity (ratio of true negative lesions to total negative lesions) and accuracy (ratio of total correct studies to the total number of biopsied lesions) of 18F-FDG PET studies performed by the BCCA will be obtained by comparing results of the PET scan with a composite of the outcome of clinical examinations, histopathological diagnosis, if those results are available, and results of all other available imaging (cardiac MRI, 201Tl, 67Ga). Confidence intervals (95% CI) for sensitivity, specificity and accuracy will be calculated using exact binomial distribution.
Study design
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 19 years or older.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 - 3.
- Able to provide written informed consent.
- Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 45 minutes and tolerating intravenous cannulation for injection.
- Clinical suspicion of cardiac sarcoidosis, including a combination of:
Key exclusion criteria (6 listed)
- Patients blood glucose > 11.1 mmol/L (200 mg/dL) measured by glucometer immediately prior to scan.
- Patients with confirmed diabetes.
- Patients unable to comply with the dietary modifications or prolonged fasting as per trial protocol.
- Pregnancy.
- Patients who are medically unstable eg. acute cardiac or respiratory distress, or hypotensive.
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-Fluorodeoxyglucose (18F-FDG) PET/CTAll subjects suspected of cardiac sarcoidosis will receive an intravenous dose of 18F-FDG (determined by weight, but not to exceed 521 MBq). Following an uptake phase of about 60 minutes, each subject will receive a PET/CT scan to evaluate the presence of cardiac sarcoidosis. | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-Fluorodeoxyglucose (18F-FDG) PET/CT in people with Cardiac Sarcoidosis, run by British Columbia Cancer Agency 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 17 inclusion and 6 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 4 Feb 2022. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 4 Feb 2022.