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

February 24, 2021 updated by: Xuejuan Wang,MD, Peking University Cancer Hospital & Institute
Using Multi-tracer to early diagnosis of therapy-associated cardiotoxicity using multimodality PET/MRI.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking university cancer hospital

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with malignant tumor after chemotherapy or immunotherapy

Description

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.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVR
Time Frame: 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.
150 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Of Mapping Value and LVEF From Baseline
Time Frame: 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
150 days

Collaborators and Investigators

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

Sponsor

Peking University Cancer Hospital & Institute

Investigators

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

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)

September 15, 2020

Primary Completion (Anticipated)

December 28, 2021

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XW-Heart-001

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

No

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.

Clinical Trials on Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe