Role of Multi-modality Imaging in the Assessment of Chemotherapy Related Cardiac Dysfunction Among Cancer Patients

January 4, 2024 updated by: John Safwat Johny, Assiut University

Assiut University-Egypt

The field of oncology has advanced remarkably. Some of the old and new emerging cancer therapies are associated with development of cardiovascular toxicities , which may have the potential to offset the gains in survival obtained with this cancer treatment advances. Much of the focus on cardiovascular toxicities has been in the early detection of myocardial damage and prediction of cancer therapeutics-related cardiac dysfunction (CTRCD). The main strategy for these patients is timely diagnosis and treatment of high-risk individual Cardiac dysfunction associated with cancer treatment is the main cause of mortality in cancer survivors. The mortality rate is recorded to be up to 60% in the first two years after therapy. The most commonly associated drugs with cardiotoxicity are anthracycline (AC) and monoclonal antibodies (such as trastuzumab). Other new agents, such as vascular endothelial growth factor (VEGF) inhibitors, immunotherapies, and proteasome inhibitors, can also cause cardiac dysfunction .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Cancer patients receiving chemotherapeutic drugs with or without adjuvant radiotherapy at oncology department of Assiut University Hospital will be enrolled and imaging modalities will be performed at Assiut University Heart Hospital.

Description

Inclusion Criteria:

  • Cancer patients ≥ 18 years of age, and scheduled to receive chemotherapy will be included.

Exclusion Criteria:

  • Contraindications to CMR (e.g.: patients with pacemakers, defibrillators or other implanted electronic devices).
  • Life expectancy ≤ 12 months.
  • Participating in another oncology clinical trial;
  • Prior exposure to chemotherapy;
  • History of active or prior cardiac disease (e.g., myocardial infarction, heart failure or base line left ventricular ejection fraction less than 55%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer patients receiving chemotherapeutic drugs
Cancer patients ≥ 18 years of age, and scheduled to receive chemotherapy will be included.
Device: Two dimensions speckle tracking and three dimension echocardiography and cardiac magnetic resonance imaging

2D speckle tracking echo will be performed before chemotherapy and after mid-cycle and after completion of treatment.

3D echo and CMR will be performed before and after chemotherapy treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine and compare the role of 2D speckle tracking vs. 3D echocardiography in assessment of early LV systolic dysfunction in patients receiving different chemotherapy combinations
Time Frame: up to 6 months after starting chemotherapy
All patient will be undergo both 2D and 3D echocardiography before and after treatment to detect early LV systolic dysfunction.
up to 6 months after starting chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: John S Johny, MSC, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Estimated)

January 15, 2024

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Cardiotoxicity and cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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