NCT05411250

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

June 6, 2022

Last Update Submit

June 6, 2022

Conditions

Positron-Emission Tomography

Keywords

cardiotoxicityearly

Outcome Measures

Primary Outcomes (1)

  • SUVmax

    the standardized uptake value

    150 days

Secondary Outcomes (1)

  • SUVR

    150 days

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with malignant tumor after chemotherapy or immunotherapy

You may qualify if:

  • No previous history of heart disease.
  • normal echocardiography, ECG and laboratory tests (creatine kinase, myoglobin, troponin, brain natriuretic peptide) before treatment.
  • F-FDG PET/CT examination before and after treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Study Officials

  • Zhi Yang, PhD

    Peking cancer hospital

    STUDY DIRECTOR

Central Study Contacts

Xuejuan Wang, MD

CONTACT

8601088196363xuejuan_wang@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal INvestigaor

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 9, 2022

Study Start

June 1, 2022

Primary Completion

May 31, 2023

Study Completion

July 31, 2023

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share