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Diagnosis of Cardiac Amyloidosis With 99mTc-PYP; Comparison Between Planar Imaging, SPECT/CT and Cardiac-dedicated CZT Camera

Primary Purpose

Cardiac Amyloidosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spect scan with mTc99-PYP
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Amyloidosis

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 will be referred for mapping using 99mTc-PYP and sign a consent form to take another photograph, under the cardiac-dedicated CZT camera

Exclusion Criteria:

1.None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cardiac amyloidosis patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    Patients who preformed mTc99-PYP for cardiac amyloidosis imaging.
    Evaluation of cardiac amyloidosis imaging with mTc99-PYP cardiac-dedicated CZT camera

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2019
    Last Updated
    November 4, 2019
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04146415
    Brief Title
    Diagnosis of Cardiac Amyloidosis With 99mTc-PYP; Comparison Between Planar Imaging, SPECT/CT and Cardiac-dedicated CZT Camera
    Official Title
    Diagnosis of Cardiac Amyloidosis With 99mTc-PYP; Comparison Between Planar Imaging, SPECT/CT and Cardiac-dedicated CZT Camera
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    November 30, 2019 (Anticipated)
    Study Completion Date
    August 1, 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
    Patients will undergo clinical and laboratory assessment, as well as imaging tests, at the discretion of the attending cardiologist and will be referred at their discretion to perform cardiac mapping using 99mTc-PYP. On the day of the examination, the examiner will be admitted to the Office of Nuclear Medicine and will be admitted to administrative. Before conducting the test, the subject will undergo a brief interview by a physician, receive an explanation of the study and, if agreed, sign an agreement to perform a further examination on the CZT camera. The patient will, as is customary, be installed on Vanflon 22 G periphery, through which a 15 millikiric (mCi) of

    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
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cardiac amyloidosis patients
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Spect scan with mTc99-PYP
    Intervention Description
    . About forty-five minutes after the injection mTc99-PYP , flanner and SPECT-CT mappings will be performed and then the patient will move to the CZT camera and undergo another photograph.
    Primary Outcome Measure Information:
    Title
    Patients who preformed mTc99-PYP for cardiac amyloidosis imaging.
    Description
    Evaluation of cardiac amyloidosis imaging with mTc99-PYP cardiac-dedicated CZT camera
    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 will be referred for mapping using 99mTc-PYP and sign a consent form to take another photograph, under the cardiac-dedicated CZT camera Exclusion Criteria: 1.None

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Diagnosis of Cardiac Amyloidosis With 99mTc-PYP; Comparison Between Planar Imaging, SPECT/CT and Cardiac-dedicated CZT Camera

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