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

• Conditions: Positron-Emission Tomography; Magnetic Resonance Imaging

• Registration Number: NCT04555642
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-14
• Study Start: 2020-09-15
• Study First Posted: 2020-09-21
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26
• Primary Completion: 2021-12-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China