Clinical trial NCT06310330: TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
Official title: Technology Revising Ultrasound Solutions for Tomorrow - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasm Malignant Primary
Keywords: echocardiography
breast cancer
artificial intelligence
cardiotoxicity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2024-03-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 1:1 to two different modes of follow-up
Primary purpose: DIAGNOSTIC

Brief summary: TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD).

Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice.

Detailed description: Cancer treatment related cardiac dysfunction (CTRCD) is a well-known complication to cancer treatment with implication both with respect to treatment and prognosis of the cancer as well as heart.

CTRCD, often named cardiotoxicity, usually refers to myocardial dysfunction and heart failure developing after administration of potentially cardiotoxic therapy. By precise diagnostics, adequate treatment can be started early to prevent heart failure and unnecessary discontinuation of the potential life-saving cancer treatment may be avoided. However, guideline advocated analyses of cardiac function (EF and GLS) by echocardiography are time consuming and many operators base their semi-quantitative estimates on visual assessment. Furthermore, test-retest variability for both EF and GLS are significant and may exceed the guideline recommended cut-offs for identification of cancer therapy-related cardiovascular toxicity.

The study will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomized design. The study will also evaluate if novel tools for improved standardization of recordings and automated measurements of relevant measurements as ejection fraction (EF) and global longitudinal strain (GLS) can improve the diagnostic precision.

Breast cancer patients referred for follow-up at the echocardiography will be included.

Patients will be randomized 1:1 to A) examinations with two- and three-dimensional echocardiography including all central measures of cardiac size and function measured by sonographers as recommended by the European guidelines and as clinical practice or B) echocardiographic examinations focusing on the ventricles.

Subpopulations will undergo additional testing with serial echocardiographic examinations by four operators on the same day with and without use of novel tools for improved standardization of recordings and automated measurements.

Eligibility criteria: Inclusion Criteria:

* Breast cancer and referral for follow-up to identify potential CTRCD

Exclusion Criteria:

* Not willing or able to consent

Primary outcomes:
measure: Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD)
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
measure: Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD)
timeFrame: 15 months
measure: Risk classification
timeFrame: 0 days
measure: Risk classification
timeFrame: 15 months
measure: Test-retest variability, systolic left ventricular size and function
timeFrame: 0 days
measure: Test-retest variability, systolic left ventricular size and function
timeFrame: 15 months
measure: Test-retest variability, diastolic left ventricular size and function
timeFrame: 0 days
measure: Test-retest variability, diastolic left ventricular size and function
timeFrame: 15 months
measure: Test-retest variability, right ventricular size and function
timeFrame: 0 days
measure: Test-retest variability, right ventricular size and function
timeFrame: 15 months
measure: Time consumption
timeFrame: 0 days
measure: Time consumption
timeFrame: 15 days
Locations:
city: Trondheim
country: Norway
facility: St. Olavs hospital
Study officials:
affiliation: St. Olavs Hospital
name: Espen Holte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: