Optimising Screening for the Cardiotoxic Effects of Cancer Therapy

NCT06817044 | Completed

• 1 other identifier: 011453
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer is a major worldwide health problem, with around 330.000 new annual cases only in the UK. Improved survival rates due to better treatments have lead to an increase in the prevalence of chemotherapy related cardiac disease (particularly with the use of anthracyclines and Trastuzumab). Since prognosis and therapeutic decisions are based on the results of these exams, the imaging technique used for sequencial follow up must faithfully reflect changes in cardiac function with the lowest intraobserver, interobserver and intra-study variabilities. The key parameter used for screening for myocardial effects of chemotherapy is the ejection fraction, measured either by echocardiography or nuclear techniques (MUGA scans) and/or CMR1. However, there are inherent problems with the sensitivity and reproducibility of ejection fraction as an imaging biomarker2,3 in this context. Advanced echocardiographic methods including myocardial strain and 3D measures offer the promise of potentially greater sensitivity for detecting early cardiac dysfunction4, however are hindered by a lack of standardisation5. Conventional CMR is the gold standard method for accuracy and reproducibility for measuring cardiac volumes and ejection fraction6, but is limited in many parts of the world by availability. To date, there is no head-to-head comparison of both accuracy and reproducibility of all three modalities performed with no temporal gap between them. The investigators will perform a multi-imaging study, where CMR, echocardiography and MUGA departments of Barts Heart Centre will work together to assess which is the best modality for cardiac surveillance in oncology patients. Whether a technique outperforms others, would clearly improve our cardio-oncology practice.

Conditions

Ventricular Dysfunction; Cardiotoxicity; Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

• Ejection fraction measurement reproducibility

  Test-retest reproducibility of ejection fraction measurements by echocardiography, nuclear imaging (MUGA) and cardiac MRI

  Single time point

Secondary Outcomes (1)

• Correlation between imaging modalities for assessment of ejection fraction

  Single time point

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients who have/ will received cardiotoxic chemotherapy

You may qualify if:

• We will include 100 patients, aged 18 or above, who are already booked for cardiac imaging investigations (MUGA scan, echocardiography (TTE) or CMR) to assess their left ventricular systolic function, as part of their routine clinical care. The majority of these patients will be patients who are being screened for cardiac toxicity resulting from cancer therapies. Some patients will be pre-treatment but many will be patients who have started treatment or completed treatment.

You may not qualify if:

• pregnancy and breast feeding.
• standard contraindications to cardiac MRI including pacemakers/implantable defibrillators, claustrophobia.
• atrial fibrillation

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts Heart Centre

London, United Kingdom

Location

MeSH Terms

Conditions

Ventricular Dysfunction; Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: February 10, 2025
• Study Start: November 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

GB (1)