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

1. 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.
2. 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.
3. The patient will, as is customary, be installed on Vanflon 22 G periphery, through which a 15 millikiric (mCi) of

Study Overview

• Status: Unknown
• Conditions: Cardiac Amyloidosis
• Intervention / Treatment: Diagnostic test: Spect scan with mTc99-PYP

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac amyloidosis patients	Diagnostic test: Spect scan with mTc99-PYP; . 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients who preformed mTc99-PYP for cardiac amyloidosis imaging.	Evaluation of cardiac amyloidosis imaging with mTc99-PYP cardiac-dedicated CZT camera	1 year

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: TASMC-18-ES-0042-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