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

Sponsor

Peking University Cancer Hospital & Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05411250

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Positron-Emission Tomography

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Outcome Measures

Primary Outcome Measures

SUVmax [150 days]
the standardized uptake value

Secondary Outcome Measures

SUVR [150 days]
the ratio of the standardized uptake value for the heart to the normal tissue such as hepatic blood poor and gluteus

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

No previous history of heart disease.
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

Exclusion Criteria:

1.receiving radiotherapy and chemotherapy at the same time. 2.previous chest radiotherapy. 3. with severe hepatic or renal dysfunction.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University Cancer Hospital & Institute

Investigators

Study Director: Zhi Yang, PhD, Peking cancer hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xuejuan Wang,MD, Principal INvestigaor, Peking University Cancer Hospital & Institute

ClinicalTrials.gov Identifier:

NCT05411250

Other Study ID Numbers:

XW-Heart-002

First Posted:

Jun 9, 2022

Last Update Posted:

Jun 9, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xuejuan Wang,MD, Principal INvestigaor, Peking University Cancer Hospital & Institute

cardiotoxicity

early

Additional relevant MeSH terms:

Cardiotoxicity

Study Results

No Results Posted as of Jun 9, 2022