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Cardiac Magnetic Resonance Imaging and echocardiography in the detection of cardiotoxicity in cancer patients: A feasibility study

To determine the feasibility of cardiac MRI, echocardiography and serum biomarkers in detecting both early and later cardiac dysfunction in cancer patients after exposure to chemotherapy and/or radiotherapy.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001238561
Acronym
CARDIAC MRI
Enrollment
44
Registered
2015-11-12
Start date
2015-10-22
Completion date
2017-12-11
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to determine the feasibility of using cardiac MRI scans, cardiac ultrasound and blood tests to detect changes in heart function following completion of chemotherapy and/or radiation therapy for cancer. Who is it for? You may be eligible to join this study if you are aged 18 or over, and have been diagnosed with breast cancer, Hodgkin's lymphoma, Non-Hodgkin's lymphoma, leukaemia or other intra-thoracic/upper gastrointestinal malignancies such as cancer of the oesophagus or thymoma, for which chemotherapy and/or radiotherapy have been prescribed. Study details All participants in this study will undergo additional cardiac screening tests at timepoints before and after chemotherapy/radiation therapy up to 12 months following the end of therapy. These tests will include MRI scans, cardiac ultrasound scans and blood samples being taken. Results from these tests will be used to assess changes in cardiac function caused by the cancer therapy. It is hoped that the findings of this feasibility trial will ultimately aid early identification of heart injury due to cancer therapy, and thus enable prevention strategies and early treatment options in these patients.

Interventions

To perform MRI, echocardiograms and serum biomarkers at pre-treatment and post-treatment time points for detection of cardiac dysfunction. Each test is an addition to standard care. The study echocardiograms and cardiac MRI scans and serum biomarkers as outlined above will be performed at 1) baseline prior to commencement of any chemotherapy or radiotherapy, then at 2) 6-8 weeks post radiotherapy and then again at approximately 12 months after completion of the last active cancer treatment (eit

To perform MRI, echocardiograms and serum biomarkers at pre-treatment and post-treatment time points for detection of cardiac dysfunction. Each test is an addition to standard care. The study echocardiograms and cardiac MRI scans and serum biomarkers as outlined above will be performed at 1) baseline prior to commencement of any chemotherapy or radiotherapy, then at 2) 6-8 weeks post radiotherapy and then again at approximately 12 months after completion of the last active cancer treatment (either chemotherapy or radiotherapy). Patients from Cohorts A to C inclusive undergoing chemotherapy prior to radiotherapy, will have their study-related imaging performed at a 2-3 week interval post chemotherapy. Patients will thus undergo a minimum of 2 and a maximum of 4 echocardiograms and cardiac MRI scans (pre and post chemotherapy, and/or pre and post radiotherapy), depending on the patient’s cancer treatment program. For each MRI scan, the patient will lay still on a flat bed which moves through a cylindrical tunnel scanner. The scan will take approximately 20 minutes. For each echocardiogram, the patient will undergo an ultra-sound test laying on a bed, and can take approximately 20 minutes. At each study time-point, cardiac toxicity will be documented by the study clinicians by taking a directed cardiac history, examination, and scoring toxicity as per the Common Terminology Criteria for Adverse Events V4 grading system, and NYHA score. All appointments will be captured and noted on the patient's electronic medical record at their hospital. Serum biomarker testing involves bloods sample taken and analysed in a laboratory.

Sponsors

Liverpool Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Cohort A – breast cancer patients (i) Aged greater than or equal to 18 years or older (ii) Histologically confirmed diagnosis of invasive breast carcinoma (iii) Receiving any anthracycline-containing breast cancer treatment regimen, including any adjuvant trastuzumab therapy AND going on to receive adjuvant left breast +/- loco-regional nodal radiotherapy, OR (iv) Receiving adjuvant left breast +/- loco-regional nodal radiotherapy alone (without chemotherapy). Acceptable radiotherapy regimens for Cohort A patients include: a)50Gy in 25 daily fractions +/- 10-16Gy tumour bed boost, over 5-6 weeks b)42.4Gy in 16 daily fractions +/- 10Gy tumour bed boost, over 3-4 weeks Cohort B – Non Hodgkin (NHL) Hodgkin lymphoma (HL) and leukaemia patients (i) Aged greater than or equal to 18 years or older (ii) Histologically confirmed diagnosis of lymphoma (iii) Receiving any anthracycline-or alkylator-containing chemotherapy regimen (eg. R-CHOP for NHL patients and ABVD for HL patients) and/or (iv) Receiving definitive or adjuvant (post-chemotherapy) radiotherapy (dose greater than or equal to 20Gy) encompassing the mediastinum (ie. including cardiac structures) Acceptable radiotherapy regimens for Cohort B patients include: *Dose ranges from 20-40Gy in 1.5-2Gy daily fractions, over 2-4 weeks Cohort C – other intra-thoracic/upper gastrointestinal malignancy patients (eg oesophageal/other eg thymoma) (i) Aged greater than or equal to 18 years or older (ii) Histologically confirmed intra-thoracic or upper gastrointestinal malignancy (iii)Receiving any neoadjuvant - and/or adjuvant or concurrent chemotherapy regimen and (iv)Receiving definitive or adjuvant radiotherapy (dose greater than or equal to 20Gy) encompassing the mediastinum (ie including cardiac structures)

Exclusion criteria

(i) any contraindication to cardiac MRI (i.e. shrapnel, metallic implants/clips, pacemaker or defibrillator); (ii) severe claustrophobia; (iii) an estimated glomerular filtration rate of less than 50 mL/min/1.732; (iv) pregnancy or breast feeding; (v) documented distant metastases from their known primary cancer; (vi) patients receiving cancer treatment with palliative intent (vii) planned or current use of other targeted biological therapies that can potentially cause cardiotoxicity (i.e. lapatinib) (viii) Pre-existing symptomatic Heart Failure (NYHA Class III or IV). (ix) Recent acute coronary syndrome (myocardial infarction, unstable angina) within the last six months (x) Recent coronary revascularization (percutaneous coronary intervention or coronary bypass surgery) within six months (xi) Permanent atrial fibrillation (xii) Prosthetic breast implants that preclude echocardiography examination

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026