Clincosm LogoSign in Get a demo

Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI

Sponsor
Peking University Cancer Hospital & Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04555642
Collaborator
(none)
120
Enrollment
1
Location
17.4
Anticipated Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Using Multi-tracer to early diagnosis of therapy-associated cardiotoxicity using multimodality PET/MRI.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this study investigators evaluated cardiac uptake by different molecular probe such as FDG, FAPI-04 using multimodality PET/MRI. Previous studies have shown that increased cardiac uptake of FDG on PET may be an indicator of myocardial injury after chemotherapy. Cardiac magnetic resonance (CMR) allows for multiparametric evaluation of cardiac morphology, ventricular function, myocardial perfusion, and viability. The combination of PET with MR (PET/MR) is therefore an alternative attractive pairing for diagnostic imaging. The aim of this study is to find noninvasive and effective method for early diagnosis of cardiotoxicity after chemotherapy or immunotherapy

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
    Actual Study Start Date :
    Sep 15, 2020
    Anticipated Primary Completion Date :
    Dec 28, 2021
    Anticipated Study Completion Date :
    Feb 28, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    therapy group

    lymphoma patients planned chemotherapy or immunotherapy scheme
    healthy control group

    Inclusion criteria for the controls were no known diseases or syndromes, within the age range from 18 to 35 years.

    Outcome Measures

    Primary Outcome Measures

    1. SUVR [150 days]

      the ratio of the standardized uptake value(SUVR) of multi-tracer for the heart within each time window to that of the normal tissue such as hepatic blood pool、blood pool and gluteus.

    Secondary Outcome Measures

    1. Change Of Mapping Value and LVEF From Baseline [150 days]

      The change of mapping value and left ventricular ejection fraction between the value before treatment and the value after treatment was calculated based on cardiac magnetic resonance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • availability of a clinical pre- and post-therapy clinical evaluation encompassing electrocardiogram (ECG) ;

    • normal findings at pre-therapy clinical evaluation;

    • cancer planned chemotherapy or immunotherapy scheme ;

    • available staging FDG-PET/CT scan (PET0);

    Exclusion Criteria:

    • cannot lie supine for half an hour;

    • refuse to join the clinical researcher;

    • without metal implants.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Cancer Hospital Beijing Beijing China 100142

    Sponsors and Collaborators

    • Peking University Cancer Hospital & Institute

    Investigators

    • Study Director: Zhi Yang, PhD, Peking University Cancer Hospital & Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xuejuan Wang,MD, Principal Investigator, Peking University Cancer Hospital & Institute
    ClinicalTrials.gov Identifier:
    NCT04555642
    Other Study ID Numbers:
    • XW-Heart-001
    First Posted:
    Sep 21, 2020
    Last Update Posted:
    Feb 26, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xuejuan Wang,MD, Principal Investigator, Peking University Cancer Hospital & Institute
    Positron-Emission Tomography
    cardiotoxicity
    Magnetic Resonance Imaging
    FDG
    FAPI
    Additional relevant MeSH terms:
    Cardiotoxicity

    Study Results

    No Results Posted as of Feb 26, 2021