Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma

Positron-Emission Tomography Clinical Trial

Official title:

Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05411250
• Other study ID #: XW-Heart-002
• Status: Not yet recruiting
• Start date: June 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: June 2022
• Source: Beijing Cancer Hospital
• Contact: Xuejuan Wang, MD
• Phone: 8601088196363
• Email: xuejuan_wang[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To explore the value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging in early diagnosis of treatment-related cardiotoxicity (TACT) of lymphoma using visual method and semi-quantitative method.

Description:

First of all, the cardiac 18F-FDG uptake in patients with lymphoma will be observed by visual method: according to the uptake site, it will be divided into left ventricular uptake and biventricular uptake, and according to the degree of uptake, it will be divided into equal uptake (myocardial uptake is lower than cardiac blood pool uptake), moderate uptake (myocardial uptake is between cardiac blood pool uptake and liver uptake) and high uptake (myocardial uptake is higher than liver uptake). According to the uptake pattern, it can be divided into diffuse and segmental uptake.Then,using the region of interest method to mesure the value of myocardial uptake of 18F-FDG.The difference value of heart's SUVmax (Δ SUVmax- heart) and% Δ SUVmax- heart before and after chemotherapy or immunotherapy will be calculated. And SUVmax- heart / SUVmax- mediastinum ratio, SUVmax- heart / SUVmax- liver ratio and SUVmax- heart / SUVmax- background ratio (left gluteal muscle) after treatment. Taking the abnormality of ECG (early TACT) as the end point.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. No previous history of heart disease.

2. normal echocardiography, ECG and laboratory tests (creatine kinase, myoglobin, troponin, brain natriuretic peptide) before treatment.

3.18F-FDG PET/CT examination before and after treatment

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Exclusion Criteria:

1.receiving radiotherapy and chemotherapy at the same time. 2.previous chest radiotherapy.

3. with severe hepatic or renal dysfunction.

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Related Conditions & MeSH terms

• Cardiotoxicity
• Positron-Emission Tomography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUVmax	the standardized uptake value	150 days
Secondary	SUVR	the ratio of the standardized uptake value for the heart to the normal tissue such as hepatic blood poor and gluteus	150 days