NCT04941248

Brief Summary

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 in severe AS patients and the impact of TAVR surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 15, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

June 27, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2026

Completed
Last Updated

March 17, 2026

Status Verified

April 1, 2025

Enrollment Period

4.5 years

First QC Date

June 15, 2021

Last Update Submit

March 14, 2026

Conditions

Cardiac Output

Keywords

Total-body; PET/CT; N-13 ammonia; Blood perfusion

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Multi-Organ Blood Perfusion by Total Body Dynamic uEXPLORER PET/CT Scan

    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

Study Arms (2)

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)

Patients with cardiac disfunction

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)

Interventions

total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)DEVICE

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.

Healthy controlsPatients with cardiac disfunction

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals aged between 60 and 90 years old with severe AS condition will be eligible for our enrollment; and participants without any history of vascular disease will be eligible.

You may qualify if:

  • 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 60\~90 years old
  • Written informed consents will be offered and signed by all participants

You may not qualify if:

  • 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 60 years old
  • Heart function grading below II(NYHA)
  • inability to lie or to maintain posture in the scanner for one hour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (10)

  • Benz DC, Ferro P, Safa N, Messerli M, von Felten E, Huang W, Patriki D, Giannopoulos AA, Fuchs TA, Grani C, Gebhard C, Pazhenkottil AP, Kaufmann PA, Buechel RR. Role of quantitative myocardial blood flow and 13N-ammonia washout for viability assessment in ischemic cardiomyopathy. J Nucl Cardiol. 2021 Feb;28(1):263-273. doi: 10.1007/s12350-019-01684-1. Epub 2019 Mar 20.

    PMID: 30895563BACKGROUND

  • Lang JK, Canty JM Jr. The complexity of using resting myocardial perfusion to assess myocardial viability and predict functional recovery. J Nucl Cardiol. 2021 Feb;28(1):274-277. doi: 10.1007/s12350-019-01742-8. Epub 2019 May 13. No abstract available.

    PMID: 31087267BACKGROUND

  • Kang KW, Kim JS, Cho SG, Kim J, Song HC. Acquisition of dynamic N-13 ammonia PET for myocardial blood flow quantification. J Nucl Cardiol. 2020 Aug;27(4):1288-1292. doi: 10.1007/s12350-020-02062-y. Epub 2020 Feb 19. No abstract available.

    PMID: 32076961BACKGROUND

  • Giubbini R, Peli A, Milan E, Sciagra R, Camoni L, Albano D, Bertoli M, Bonacina M, Motta F, Statuto M, Rodella CA, De Agostini A, Calabretta R, Bertagna F; Italian Nuclear Cardiology Group (GICN). Comparison between the summed difference score and myocardial blood flow measured by 13N-ammonia. J Nucl Cardiol. 2018 Oct;25(5):1621-1628. doi: 10.1007/s12350-017-0789-z. Epub 2017 Feb 3.

    PMID: 28160262BACKGROUND

  • Sciagra R, Lubberink M, Hyafil F, Saraste A, Slart RHJA, Agostini D, Nappi C, Georgoulias P, Bucerius J, Rischpler C, Verberne HJ; Cardiovascular Committee of the European Association of Nuclear Medicine (EANM). EANM procedural guidelines for PET/CT quantitative myocardial perfusion imaging. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1040-1069. doi: 10.1007/s00259-020-05046-9. Epub 2020 Nov 2.

    PMID: 33135093BACKGROUND

  • Lammertsma AA. Forward to the Past: The Case for Quantitative PET Imaging. J Nucl Med. 2017 Jul;58(7):1019-1024. doi: 10.2967/jnumed.116.188029. Epub 2017 May 18.

    PMID: 28522743BACKGROUND

  • Akamatsu G, Uba K, Taniguchi T, Mitsumoto K, Narisue A, Tsutsui Y, Sasaki M. Impact of Time-of-Flight PET/CT with a Large Axial Field of View for Reducing Whole-Body Acquisition Time. J Nucl Med Technol. 2014 Jun;42(2):101-4. doi: 10.2967/jnmt.114.140665. Epub 2014 May 5.

    PMID: 24799607BACKGROUND

  • Zhang X, Cherry SR, Xie Z, Shi H, Badawi RD, Qi J. Subsecond total-body imaging using ultrasensitive positron emission tomography. Proc Natl Acad Sci U S A. 2020 Feb 4;117(5):2265-2267. doi: 10.1073/pnas.1917379117. Epub 2020 Jan 21.

    PMID: 31964808BACKGROUND

  • Zhang X, Xie Z, Berg E, Judenhofer MS, Liu W, Xu T, Ding Y, Lv Y, Dong Y, Deng Z, Tang S, Shi H, Hu P, Chen S, Bao J, Li H, Zhou J, Wang G, Cherry SR, Badawi RD, Qi J. Total-Body Dynamic Reconstruction and Parametric Imaging on the uEXPLORER. J Nucl Med. 2020 Feb;61(2):285-291. doi: 10.2967/jnumed.119.230565. Epub 2019 Jul 13.

    PMID: 31302637BACKGROUND

  • Cherry SR, Jones T, Karp JS, Qi J, Moses WW, Badawi RD. Total-Body PET: Maximizing Sensitivity to Create New Opportunities for Clinical Research and Patient Care. J Nucl Med. 2018 Jan;59(1):3-12. doi: 10.2967/jnumed.116.184028. Epub 2017 Sep 21.

    PMID: 28935835BACKGROUND

Study Officials

  • Yumei Chen, Ph.D; M.D.

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy head of the department of nuclear medicine

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 28, 2021

Study Start

June 27, 2021

Primary Completion

January 8, 2026

Study Completion

February 8, 2026

Last Updated

March 17, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)