Cardiac AmyloidosisNCT04146480
The Potential Role of 18F-NaF PET/CT in Diagnosing Cardiac Amyloidosis
A study testing F18-NaF PET/CT in people with Cardiac Amyloidosis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Cardiac amyloidosis is a common cause of refractory cardiomyopathy and heart failure in an adult population. There are several types of cardiac amyloidosis, but two are the most common (1): A. AL - Light chain sunset. B. ATTR - Sunset of transthyretin protein. This amyloidosis has two subtypes: 1. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- F18-NaF PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2018to 24 Jul 2020
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing "cardiac amyloidosis clinic" at Tel Aviv Medical Center and there is a clinical suspicion of having cardiac amyloidosis.
- Patients who performed 99mTc-PYP mapping and signed an informed consent form to perform another imaging test, namely, 18F-NaF PET / CT.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky medial center, Tel Aviv, Israel
Tel Aviv, Central District, 6436110
ira korovin, 036974373, irako@tlvmc.gov.il
About this study
Cardiac amyloidosis is a common cause of refractory cardiomyopathy and heart failure in an adult population. There are several types of cardiac amyloidosis, but two are the most common (1):
- AL - Light chain sunset.
- ATTR - Sunset of transthyretin protein. This amyloidosis has two subtypes:
- Hereditary / familial - due to genetic mutation
- Senile / Wild-type (WT) - Acquired with age
The main goal of this study is to evaluate cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantification of absorption [in standard uptake value SUVs]. and to compare cardiac amyloidosis imaging using 18F-NaF PET / CT and gamma camera imaging with 99mTc-PYP.
Read the detailed description
PET imaging has advantages over gamma imaging, including better resolution, faster and easier testing, and the ability to quantify the absorption intensity. These PET capabilities, potentially, detect subtle differences in disease burden between different heart segments and, subsequently, track response to treatment.
Research Duration:
The entire duration of the study will take about one year (or until all participants in the study complete the tests), As part of the study, tests will be conducted for 20 subjects.
Program details and research steps:
- The study is a prospective study.
- The research was done in collaboration with Prof. Eyal Masheni, Director of the Cyclotron and Radiochemistry Unit at Hadassah Hospital, which will provide twenty doses of 18F-NaF.
- For the Cyclotron and Radiochemistry Unit in Hadassah Hospital, a license to operate as a radiopharmaceutical pharmacy on behalf of the Ministry of Health, and thus valid, a blanket approval by the Ministry of Health to use the materials manufactured therein.
Research phases:
- Patients will undergo clinical and laboratory evaluation, as well as imaging tests, at the discretion of the treating cardiologist, even before being referred for examination within the study. At this stage, patients will be recruited for the study and given an explanation of the tests that will be passed. If necessary, patients will be referred to the Institute of Nuclear Medicine for more information.
- The test will be performed on the Discovery 690 Nuclear Medicine Camera.
- On the day of the examination, the examiner will be admitted to the Office of the Institute of Nuclear Medicine and will be admitted to administrative. Prior to the test, the subject will undergo a brief interview by a physician or nurse and a 22 G Prefill will be installed on him, through which a 5 millikiric (mCi) of 18 F-NaF will be injected.
- An hour after the injection, the PET / CT test, which will last for about 10 minutes, will be performed during which the patient is required to rest comfortably and breathe normally.
- Upon completion of the mapped examination, the home will be released without any restrictions.
- Continued clinical follow-up will be done by the attending cardiologist.
- Conditions
- Cardiac Amyloidosis
- Being tested
- F18-NaF PET/CT
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F18-NaF PET/CTDiagnostic test
The scan will be performed on the Discovery 690 Nuclear Medicine Camera. On the day of the scan, the patient will be admitted to the Office of Nuclear Medicine and will be admitted to administrative. Prior to the scan, the subject will undergo a brief interview by a physician or nurse and a 22 G Prefill will be installed on him, through which a 5 millikiric (mCi) of 18 F-NaF will be injected.
- An hour after the injection, the PET / CT scan, which will last about 10 minutes, during, the patient is required to lie down and breathe normally.
- Upon completion of the scan, will be released without any restrictions.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac amyloidosis patients | Experimental | Not described Receives: Diagnostic Test: F18-NaF PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantifying the extent of absorption in SUV standard uptake value
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Jul 2018
- Primary completion31 Jul 2018
- Study completion24 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146480
- Sponsor's protocol ID
- TASMC-17-ES-0807-CTIL
- Status last verified
- May 2019
- First submitted
- 29 Oct 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of 18F-NaF PET/CT in Diagnosing Cardiac Amyloidosis
- ClinicalTrials.gov ID
- NCT04146480
- Acronym / sponsor ID
- TASMC-17-ES-0807-CTIL
- Conditions
- Cardiac Amyloidosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 24 Jul 2020 (estimated)
- First posted
- 31 Oct 2019 (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.
Cardiac amyloidosis is a common cause of refractory cardiomyopathy and heart failure in an adult population. There are several types of cardiac amyloidosis, but two are the most common (1):
- AL - Light chain sunset.
- ATTR - Sunset of transthyretin protein. This amyloidosis has two subtypes:
- Hereditary / familial - due to genetic mutation
- Senile / Wild-type (WT) - Acquired with age
The main goal of this study is to evaluate cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantification of absorption [in standard uptake value SUVs]. and to compare cardiac amyloidosis imaging using 18F-NaF PET / CT and gamma camera imaging with 99mTc-PYP.
Detailed description
PET imaging has advantages over gamma imaging, including better resolution, faster and easier testing, and the ability to quantify the absorption intensity. These PET capabilities, potentially, detect subtle differences in disease burden between different heart segments and, subsequently, track response to treatment.
Research Duration:
The entire duration of the study will take about one year (or until all participants in the study complete the tests), As part of the study, tests will be conducted for 20 subjects.
Program details and research steps:
- The study is a prospective study.
- The research was done in collaboration with Prof. Eyal Masheni, Director of the Cyclotron and Radiochemistry Unit at Hadassah Hospital, which will provide twenty doses of 18F-NaF.
- For the Cyclotron and Radiochemistry Unit in Hadassah Hospital, a license to operate as a radiopharmaceutical pharmacy on behalf of the Ministry of Health, and thus valid, a blanket approval by the Ministry of Health to use the materials manufactured therein.
Research phases:
- Patients will undergo clinical and laboratory evaluation, as well as imaging tests, at the discretion of the treating cardiologist, even before being referred for examination within the study. At this stage, patients will be recruited for the study and given an explanation of the tests that will be passed. If necessary, patients will be referred to the Institute of Nuclear Medicine for more information.
- The test will be performed on the Discovery 690 Nuclear Medicine Camera.
- On the day of the examination, the examiner will be admitted to the Office of the Institute of Nuclear Medicine and will be admitted to administrative. Prior to the test, the subject will undergo a brief interview by a physician or nurse and a 22 G Prefill will be installed on him, through which a 5 millikiric (mCi) of 18 F-NaF will be injected.
- An hour after the injection, the PET / CT test, which will last for about 10 minutes, will be performed during which the patient is required to rest comfortably and breathe normally.
- Upon completion of the mapped examination, the home will be released without any restrictions.
- Continued clinical follow-up will be done by the attending cardiologist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac amyloidosis patients | Experimental | Diagnostic Test: F18-NaF PET/CT |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing "cardiac amyloidosis clinic" at Tel Aviv Medical Center and there is a clinical suspicion of having cardiac amyloidosis.
- Patients who performed 99mTc-PYP mapping and signed an informed consent form to perform another imaging test, namely, 18F-NaF PET / CT.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| F18-NaF PET/CTThe scan will be performed on the Discovery 690 Nuclear Medicine Camera. On the day of the scan, the patient will be admitted to the Office of Nuclear Medicine and will be admitted to administrative. Prior to the scan, the subject will undergo a brief interview by a physician or nurse and a 22 G Prefill will be installed on him, through which a 5 millikiric (mCi) of 18 F-NaF will be injected. 4. An hour after the injection, the PET / CT scan, which will last about 10 minutes, during, the patient is required to lie down and breathe normally. 5. Upon completion of the scan, will be released without any restrictions. | Diagnostic test | Cardiac amyloidosis patients |
Primary outcome
Evaluating cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantifying the extent of absorption in SUV standard uptake value
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Amyloidosis
Active, not recruitingObservational study
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EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
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Essen Amyloidosis Registry
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MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F18-NaF PET/CT in people with Cardiac Amyloidosis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 inclusion and 1 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 31 Oct 2019. 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 Israel. 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?
Contact Ira korovin (036974373, irako@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantifying the extent of absorption in SUV standard uptake value (time frame: 1 year). 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 31 Oct 2019.