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Trial Title:
TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography
NCT ID:
NCT06310330
Condition:
Breast Neoplasm Malignant Primary
Conditions: Official terms:
Breast Neoplasms
Neoplasms
Cardiotoxicity
Conditions: Keywords:
echocardiography
breast cancer
artificial intelligence
cardiotoxicity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomization 1:1 to two different modes of follow-up
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Masking description:
No masking
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Comprehensive echocardiographic follow-up
Description:
Comprehensive echocardiographic follow-up for identification of CRTCD in breast cancer
patients
Arm group label:
Usual care
Intervention type:
Diagnostic Test
Intervention name:
Simplified echocardiographic follow-up
Description:
Simplified echocardiographic follow-up for identification of CRTCD in breast cancer
patients
Arm group label:
Simplified care
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Breast cancer and referral for follow-up to identify potential CTRCD
Exclusion Criteria:
- Not willing or able to consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Olavs hospital
Address:
City:
Trondheim
Zip:
7491
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Rune Wiseth, MD, PhD
Phone:
92247845
Phone ext:
47
Email:
rune.wiseth@stolav.no
Start date:
March 8, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Norwegian University of Science and Technology
Agency class:
Other
Collaborator:
Agency:
St. Olavs Hospital
Agency class:
Other
Source:
Norwegian University of Science and Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06310330
