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Trial registered on ANZCTR
Registration number
ACTRN12622000681752
Ethics application status
Approved
Date submitted
13/04/2022
Date registered
11/05/2022
Date last updated
20/04/2023
Date data sharing statement initially provided
11/05/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Sensitivity and specificity of FAPI-PET in type 1 and 2 chemotherapy induced cardiotoxicity
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Scientific title
Sensitivity and specificity of FAPI-PET in type 1 and 2 chemotherapy induced cardiotoxicity
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Secondary ID [1]
306860
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
HEART
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chemotherapy induced cardiotoxicity
325949
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cancer
325950
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Condition category
Condition code
Cardiovascular
323260
323260
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0
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Other cardiovascular diseases
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Cancer
323261
323261
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0
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Any cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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
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Intervention code [1]
323322
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Early detection / Screening
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Intervention code [2]
323323
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Diagnosis / Prognosis
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Comparator / control treatment
No Control Group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Number of patients with cardiac uptake of [68Ga] Ga-FAPI PET/CT deemed diagnostic by study criteria.
Image analysis study criteria
The 68Ga-FAPI PET will be reviewed by two experienced reporters: a nuclear medicine physician, nuclear cardiologist or PET trained radiologist.
Cardiac uptake will be assessed as present or absent above cardiac chamber blood pool activity. The pattern of uptake will be noted and the degree of uptake assessed at standardised uptake value (SUV) maximum and peak corrected for lean body mass. Total cardiac uptake will be estimated. Comparison of the baseline and follow up PETs will be made and correlation with baseline and follow up LVEF by echocardiography.
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Assessment method [1]
331003
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Timepoint [1]
331003
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completion of the trial
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Primary outcome [2]
331004
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Patient Outcome related to cardiac function
Cardiac function will be assessed through echocardiography LVEF assessments.
This assessments will be part of normal clinical care but the results will be shared with the research team.
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Assessment method [2]
331004
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Timepoint [2]
331004
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completion of the trial
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Secondary outcome [1]
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The number of patients in both groups completing all three 68Ga-FAPI PET cardiac assessments and echocardiography LVEF assessments.
This data will be collected on study visits and study records will be analysed in order to reach an outcome.
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Assessment method [1]
408458
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Timepoint [1]
408458
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Completion of the trial
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Secondary outcome [2]
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Patient screening rate (number of screened over time); enrolment rate (number of enrolled overtime);screening failure (total number of enrolled/total number of screened); reasons for screening failure.
This data will be collected via study visits and telephone follow ups
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Assessment method [2]
408459
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Timepoint [2]
408459
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Completion of the trial
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Secondary outcome [3]
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Retention rate (number of patients completing the study /number of patients enrolled) and reasons for discontinuing the study before completion.
this data will be collected via audit of study records
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Assessment method [3]
408460
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Timepoint [3]
408460
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completion of the trial
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Eligibility
Key inclusion criteria
Age > 18
ECOG performance 0-2
ability to give informed consent
willing to use contraception for the duration of the study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Previous malignancy
Previous chemotherapy (apart from anthracycline therapy prior to Trastuzumab therapy)
Previous mediastinal radiotherapy
Known Coronary Artery Disease
Hypertension
Diabetes
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
8/07/2024
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Actual
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Date of last participant enrolment
Anticipated
11/08/2025
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Actual
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Date of last data collection
Anticipated
3/08/2026
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
24710
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New Zealand
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State/province [1]
24710
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
311181
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Primary sponsor type
Commercial sector/Industry
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Name
Mercy Radiology
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Address
98 Mountain Road, Epsom, Auckland 1023
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
312541
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Address [1]
312541
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Country [1]
312541
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310712
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
310712
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
310712
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New Zealand
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Date submitted for ethics approval [1]
310712
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28/09/2022
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Approval date [1]
310712
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17/10/2022
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Ethics approval number [1]
310712
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Andrew Henderson
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Address
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Mercy Radiology
98 Mountain Road
Epsom
Auckland 1023
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Country
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New Zealand
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Phone
118606
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+6402040926652
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Fax
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Email
118606
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[email protected]
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Contact person for public queries
Name
118607
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Mrs Rosane Joseph
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Address
118607
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Mercy Radiology
98 Mountain Road
Epsom
Auckland 1023
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Country
118607
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New Zealand
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Phone
118607
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+64096302234
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Fax
118607
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Email
118607
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[email protected]
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Contact person for scientific queries
Name
118608
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Dr Andrew Henderson
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Address
118608
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Mercy Radiology
98 Mountain Road
Epsom
Auckland 1023
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Country
118608
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New Zealand
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Phone
118608
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+6402040926652
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Fax
118608
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Email
118608
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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