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

Magnetic Resonance Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04555642
• Other study ID #: XW-Heart-001
• Status: Recruiting
• Start date: September 15, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2021
• Source: Beijing Cancer Hospital
• Contact: Xuejuan Wang, MD
• Phone: 86 010 88196363
• Email: xuejuan_wang[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 28, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiotoxicity
• Magnetic Resonance Imaging
• Positron-Emission Tomography

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUVR	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	Change Of Mapping Value and LVEF From Baseline	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