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

NCT ID: NCT04941248

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-27

Study Completion Date

2025-12-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Output

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy controls

All healthy subjects will undergo the following intervention: 13N-NH3 PET/CT scan on the total-body uEXPLORER scanner.

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

Intervention Type 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.

Patients with decreased cardiac function

All patients will undergo the following intervention: 13N-NH3 PET/CT scan on the total-body uEXPLORER scanner.

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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 60\~90 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 60 years old
* Heart function grading below II(NYHA)
* inability to lie or to maintain posture in the scanner for one hour
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yumei Chen

deputy head of the department of nuclear medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yumei Chen, Ph.D; M.D.

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Shanghai jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yumei Chen, Ph.D; M.D.

Role: CONTACT

86-021-58752345

Xiaofeng Yu

Role: CONTACT

86-021-58752345

Facility Contacts

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Yumei Chen, Ph.D;M.D.

Role: primary

86-021-58752345

References

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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.

Reference Type BACKGROUND
PMID: 30895563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31087267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32076961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28160262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33135093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28522743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24799607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31964808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31302637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28935835 (View on PubMed)

Other Identifiers

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KY2021-086

Identifier Type: -

Identifier Source: org_study_id

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