Trial Review

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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
Scientific title
Sensitivity and specificity of FAPI-PET in type 1 and 2 chemotherapy induced cardiotoxicity
Secondary ID [1] 306860 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
HEART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chemotherapy induced cardiotoxicity 325949 0
cancer 325950 0
Condition category
Condition code
Cardiovascular 323260 323260 0 0
Other cardiovascular diseases
Cancer 323261 323261 0 0
Any cancer

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 323322 0
Early detection / Screening
Intervention code [2] 323323 0
Diagnosis / Prognosis
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331003 0
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.
Timepoint [1] 331003 0
completion of the trial
Primary outcome [2] 331004 0
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.
Timepoint [2] 331004 0
completion of the trial
Secondary outcome [1] 408458 0
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.
Timepoint [1] 408458 0
Completion of the trial
Secondary outcome [2] 408459 0
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
Timepoint [2] 408459 0
Completion of the trial
Secondary outcome [3] 408460 0
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
Timepoint [3] 408460 0
completion of the trial

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous malignancy
Previous chemotherapy (apart from anthracycline therapy prior to Trastuzumab therapy)
Previous mediastinal radiotherapy
Known Coronary Artery Disease
Hypertension
Diabetes

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2024
Actual
Date of last participant enrolment
Anticipated
11/08/2025
Actual
Date of last data collection
Anticipated
3/08/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 24710 0
New Zealand
State/province [1] 24710 0

Funding & Sponsors
Funding source category [1] 311181 0
Self funded/Unfunded
Name [1] 311181 0
Country [1] 311181 0
Primary sponsor type
Commercial sector/Industry
Name
Mercy Radiology
Address
98 Mountain Road, Epsom, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 312541 0
None
Name [1] 312541 0
Address [1] 312541 0
Country [1] 312541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310712 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310712 0
Ethics committee country [1] 310712 0
New Zealand
Date submitted for ethics approval [1] 310712 0
28/09/2022
Approval date [1] 310712 0
17/10/2022
Ethics approval number [1] 310712 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118606 0
Dr Andrew Henderson
Address 118606 0
Mercy Radiology
98 Mountain Road
Epsom
Auckland 1023
Country 118606 0
New Zealand
Phone 118606 0
+6402040926652
Fax 118606 0
Email 118606 0
ahenderson@radiology.co.nz
Contact person for public queries
Name 118607 0
Rosane Joseph
Address 118607 0
Mercy Radiology
98 Mountain Road
Epsom
Auckland 1023
Country 118607 0
New Zealand
Phone 118607 0
+64096302234
Fax 118607 0
Email 118607 0
rjoseph@radiology.co.nz
Contact person for scientific queries
Name 118608 0
Andrew Henderson
Address 118608 0
Mercy Radiology
98 Mountain Road
Epsom
Auckland 1023
Country 118608 0
New Zealand
Phone 118608 0
+6402040926652
Fax 118608 0
Email 118608 0
ahenderson@radiology.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.