Total-body 13N-NH3 PET/CT to Study the Blood Perfusion in Whole Body

April 8, 2024 updated by: Yumei Chen, RenJi Hospital

The Application of Total-body 13N-NH3 PET/CT to Study the Blood Perfusion System in the Whole Body

The aim of our study is to analyze and quantitate whole-body blood perfusion by total-body 13N-NH3 PET/CT(uEXPLORER), and evaluate the influence to other organs caused by the decreased cardiac function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants are invited to participate in a research that seeks to understand the dynamic blood perfusion in human body. The investigators expect to have twenty-five participants in this study at Renji Hospital, Shanghai. About sixteen of the participants will be patients who have been diagnosed with decreased cardiac function, nine participants will be healthy individuals with no known vascular disease. These healthy subjects will allow researchers to compare blood perfusion difference with those of persons with decreased cardiac function. All the participants will undergo the same procedure.

If participants agree to participate in this study, researchers will first interview participants and review the past medical record in order to document the medical history. When the screening procedures confirm that participants are eligible to participate in the study, participants will receive one dose of the non-therapeutic administration of a radioactive tracer called N-13 ammonia(13NH3) , then undergo one total body 13NH3 PET/CT Scan (uEXPLORER) to determine the blood flow value of the brain, kidney and other organs. The total body 13NH3 PET/CT Scan will allow investigators to observe and analyze the real-time blood flow differences between patients with between healthy controls and decreased cardiac function.

Study Type

Observational

Enrollment (Estimated)

25

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 Backup

  • Name: Yumei Chen, Ph.D; M.D.
  • Phone Number: 86-021-58752345
  • Email: cymrenji@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • shanghai Jiaotong University School of Medicine, Renji Hospital
        • 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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals aged between 18 and 85 years old with decreased cardiac function will be eligible for our enrollment; and participants without any history of vascular disease will be eligible.

Description

Inclusion Criteria:

  • Nine healthy volunteers with normal EF values
  • Patients with decreased cardiac function, while their heart function grading above II(New York Heart Association,NYHA)
  • Aged 18~85 years old
  • Written informed consents will be offered and signed by all participants

Exclusion Criteria:

  • History of vascular-related diseases in other organs
  • Severe liver and kidney dysfunctions
  • Patients who are pregnant or breast feeding
  • People under the age of 18 years old
  • Heart function grading below II(NYHA)
  • inability to lie or to maintain posture in the scanner for one hour

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
All healthy subjects will undergo the following intervention: 13N-NH3 PET/CT scan on the total-body uEXPLORER scanner.
Device: total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)
This prospective study will enroll twenty-five patients, including nine healthy volunteers, sixteen patients with decreased cardiac function . All of them will have a whole-body PET/CT(uEXPLORER , United Imaging Healthcare, China) in our department, Renji Hospital.
Patients with decreased cardiac function
All patients will undergo the following intervention: 13N-NH3 PET/CT scan on the total-body uEXPLORER scanner.
Device: total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)
This prospective study will enroll twenty-five patients, including nine healthy volunteers, sixteen patients with decreased cardiac function . All of them will have a whole-body PET/CT(uEXPLORER , United Imaging Healthcare, China) in our department, Renji Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Multi-Organ Blood Perfusion by Total Body Dynamic uEXPLORER PET/CT Scan
Time Frame: 4 years
The total-body 13N-NH3 PET/CT will be adopted to evaluate the blood flow differences in whole body between healthy controls and patients with decreased cardiac function.
4 years

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Yumei Chen, Ph.D; M.D., Shanghai Jiaotong University School of Medicine,Renji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 27, 2021

Primary Completion (Estimated)

June 8, 2024

Study Completion (Estimated)

December 8, 2024

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 20, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KY2021-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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