The Potential Role of 18F-NaF PET/CT in Diagnosing Cardiac Amyloidosis

October 29, 2019 updated by: Tel-Aviv Sourasky Medical Center

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. Hereditary / familial - due to genetic mutation
  2. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. 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.
  2. The test will be performed on the Discovery 690 Nuclear Medicine Camera.
  3. 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.
  4. 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.
  5. Upon completion of the mapped examination, the home will be released without any restrictions.
  6. Continued clinical follow-up will be done by the attending cardiologist.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
    • Hamerkaz
      • Tel Aviv, Hamerkaz, Israel, 6436110
        • Recruiting
        • Tel Aviv Sourasky medial center, Tel Aviv, Israel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cardiac amyloidosis patients
Diagnostic test: F18-NaF PET/CT

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TASMC-17-ES-0807-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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