ACTRN12615001238561
Completed
未知
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.
iverpool Hospital0 sites44 target enrollmentNovember 12, 2015
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cardiac dysfunction
- Sponsor
- iverpool Hospital
- Enrollment
- 44
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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