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

Not Applicable

Completed

• Conditions: leukaemia; Radiotherapy related toxicity; Cardiovascular - Other cardiovascular diseases; Cancer - Breast; Breast Cancer; Intra-thoracic cancer; Lymphoma; Oesophageal cancer; Chemotherapy related toxicity; Cardiovascular - Normal development and function of the cardiovascular system

• Registration Number: ACTRN12615001238561
• Lead Sponsor: iverpool Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-12
• Study Completion: 2019-09-02
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the feasibility of cardiac MRI and heart ultrasound in detecting both early and later cardiac dysfunction in breast and intra-thoracic cancer patients after exposure to chemotherapy and/or radiotherapy.<br><br>Comparisons of echocardiography with cardiac MRI with routine GHPS (documenting<br>LVEF) performed pre-chemotherapy, at each of these time points will be undertaken.<br>[composite primary outcome 1][Baseline and early i.e. 6-8 weeks post radiotherapy completion, and later, i.e. up to 12 months after exposure to cardiotoxic chemotherapy and/or local radiotherapy.]