The Potential Role of 18F-NaF PET/CT in Diagnosing Cardiac Amyloidosis
Primary Purpose
Cardiac Amyloidosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
F18-NaF PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Amyloidosis
Eligibility Criteria
Inclusion Criteria:
A. Patients undergoing "cardiac amyloidosis clinic" at Tel Aviv Medical Center and there is a clinical suspicion of having cardiac amyloidosis.
B. Patients who performed 99mTc-PYP mapping and signed an informed consent form to perform another imaging test, namely, 18F-NaF PET / CT.
Exclusion Criteria:
None
Sites / Locations
- Tel Aviv Sourasky medial center, Tel Aviv, IsraelRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiac amyloidosis patients
Arm Description
Outcomes
Primary Outcome Measures
Evaluating cardiac amyloidosis imaging efficiency using 18F-NaF PET / CT and quantifying the extent of absorption in SUV standard uptake value
Secondary Outcome Measures
Full Information
NCT ID
NCT04146480
First Posted
October 29, 2019
Last Updated
October 29, 2019
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04146480
Brief Title
The Potential Role of 18F-NaF PET/CT in Diagnosing Cardiac Amyloidosis
Official Title
The Potential Role of 18F-NaF PET/CT in Diagnosing Cardiac Amyloidosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 24, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiac amyloidosis patients
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
F18-NaF PET/CT
Intervention Description
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.
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A. Patients undergoing "cardiac amyloidosis clinic" at Tel Aviv Medical Center and there is a clinical suspicion of having cardiac amyloidosis.
B. Patients who performed 99mTc-PYP mapping and signed an informed consent form to perform another imaging test, namely, 18F-NaF PET / CT.
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ira korovin
Phone
036974373
Email
irako@tlvmc.gov.il
Facility Information:
Facility Name
Tel Aviv Sourasky medial center, Tel Aviv, Israel
City
Tel Aviv
State/Province
Hamerkaz
ZIP/Postal Code
6436110
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ira korovin
Phone
036974373
Email
irako@tlvmc.gov.il
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Potential Role of 18F-NaF PET/CT in Diagnosing Cardiac Amyloidosis
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