None listed
Conditions
Brief summary
Monitoring chemotherapy induced cardiotoxicity is a crucial part of the management of a significant cohort of cancer patients. Current assessments for cardiotoxicity rely on detection of early cardiac injury, reflected by measurable left ventricular dysfunction. Up to 50% of patients with early chemotherapy induced cardiotoxicity have a normal left ventricular function but their prognosis is similar to those identified early with reduced left ventricular function. Detection of patients developing chemotherapy induced cardiotoxicity prior to irreversible cardiac injury would be ideal. 68Ga-FAPI is increasingly used in the staging of various cancers. Various studies describe the phenomenon of myocardial FAPI uptake in patients who received a Ga-68 FAPI PET for tumour staging. The Hypothesis is that 68Ga-FAPI may be a predictor of chemotherapy related cardiotoxicity prior to commencing treatment. 68Ga-FAPI may also be a sensitive marker for early cardiac injury related to chemotherapy. there is a potential that this trial may show 68Ga-FAPI to be a more effective diagnostic and surveillance tool in detecting cardiac toxicity related to chemotherapy. As a result this will afford those patients a better quality of life and increased survival.
Interventions
This is a prospective open label nonrandomized clinical trial designed to evaluate 68Ga-FAPI as a marker for early cardiac injury related to chemotherapy as well as potentially predicting those more at risk of such injury.
A total of 20 patients will be recruited of which 10 will be receiving a type 1 cardiotoxic agent and 10 a type 2 cardiotoxic agent. Patients will have a total of three 68Ga-FAPI PET/CTs at Baseline, 6months and 12 months
Patients will receive 200-300 MBq radiation dose of
This is a prospective open label nonrandomized clinical trial designed to evaluate 68Ga-FAPI as a marker for early cardiac injury related to chemotherapy as well as potentially predicting those more at risk of such injury. A total of 20 patients will be recruited of which 10 will be receiving a type 1 cardiotoxic agent and 10 a type 2 cardiotoxic agent. Patients will have a total of three 68Ga-FAPI PET/CTs at Baseline, 6months and 12 months Patients will receive 200-300 MBq radiation dose of 68Ga-FAPI The IMP will be administered intravenously Patients can expect the below assessments during study visits Analysis of Echocardiography results done as standard care ECG (QT interval; HR) Blood Pressure Each study visit will last in average 2 hours Compliance will be calculated based on attendance records
Sponsors
Mercy Radiology
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
Age > 18 ECOG performance 0-2 ability to give informed consent willing to use contraception for the duration of the study
Exclusion criteria
Previous malignancy Previous chemotherapy (apart from anthracycline therapy prior to Trastuzumab therapy) Previous mediastinal radiotherapy Known Coronary Artery Disease Hypertension Diabetes
Outcome results
None listed