NCT04555642

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 31, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

August 31, 2020

Last Update Submit

February 24, 2021

Conditions

Positron-Emission TomographyMagnetic Resonance Imaging

Keywords

Positron-Emission TomographycardiotoxicityMagnetic Resonance ImagingFDGFAPI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change Of Mapping Value and LVEF From Baseline

    150 days

Study Arms (2)

therapy group

lymphoma patients planned chemotherapy or immunotherapy scheme

healthy control group

Inclusion criteria for the controls were no known diseases or syndromes, within the age range from 18 to 35 years.

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:

  • 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);

You may not qualify if:

  • cannot lie supine for half an hour;
  • refuse to join the clinical researcher;
  • without metal implants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

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 University Cancer Hospital & Institute

    STUDY DIRECTOR

Central Study Contacts

Xuejuan Wang, MD

CONTACT

86 010 88196363xuejuan_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 Investigator

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 21, 2020

Study Start

September 15, 2020

Primary Completion

December 28, 2021

Study Completion

February 28, 2022

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)