NCT04146415

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

29 days

First QC Date

October 29, 2019

Last Update Submit

November 4, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients who preformed mTc99-PYP for cardiac amyloidosis imaging.

    Evaluation of cardiac amyloidosis imaging with mTc99-PYP cardiac-dedicated CZT camera

    1 year

Study Arms (1)

Cardiac amyloidosis patients

EXPERIMENTAL
Diagnostic Test: Spect scan with mTc99-PYP

Interventions

. 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.

Cardiac amyloidosis patients

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Interventions

Tomography, Emission-Computed, Single-Photon

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis Deficiencies

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2019

First Posted

October 31, 2019

Study Start

November 1, 2019

Primary Completion

November 30, 2019

Study Completion

August 1, 2020

Last Updated

November 6, 2019

Record last verified: 2019-11