Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000637741
Ethics application status
Approved
Date submitted
13/04/2022
Date registered
2/05/2022
Date last updated
20/04/2023
Date data sharing statement initially provided
2/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Studying the utility of [68Ga] FAPI PET CT in Cardiac Sarcoidosis – a pilot study
Scientific title
Studying the utility of [68Ga] FAPI PET CT in Cardiac Sarcoidosis – a pilot study
Secondary ID [1] 306855 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
DETECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Sarcoidosis 325946 0
Condition category
Condition code
Cardiovascular 323256 323256 0 0
Other cardiovascular diseases
Inflammatory and Immune System 323257 323257 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This Study is a Open label , non randomized prospective pilot.

We plan to conduct a prospective, observational, pilot study on 10 consecutively recruited patients with known cardiac sarcoidosis, on the basis of current accepted diagnostic criteria.
Eligible patients will be referred by their Cardiologist to the Mercy Radiology.
A member of the Research team will contact those patients to confirm eligibility and willingness to participate. Once patients have been recruited they will undergo a PET CT scan using [68Ga]Ga-FAPI.
We will analyse:
Patient screening rate (number of screened over time); enrolment rate (number of enrolled over time); screening failure (total number of enrolled/total number of screened); reasons for screening failure

Retention rate (number of patients completing the study /number of patients enrolled) and reasons for discontinuing the study before completion.

This information will determine feasibility for a larger multicentre trial

We will also analyse:

Number of patients with cardiac uptake at [68Ga]Ga-FAPI PET/CT deemed diagnostic by study criteria

This information will determine if [68Ga]Ga-FAPI is a more effective agent in diagnosing cardiac sarcoidosis.
Patients will receive 1 dose of [68Ga]Ga-FAPI before their PET scan. Average radiation dose of 260MBq. The Agent will be administered intravenously
So far there is no known adverse effects of FAPI serious or otherwise
The radiation exposure is considerably lower than imaging agents currently used
Patients can expect a single visit to our PETCT department.
The study visit will last approximately 2 hours
Intervention code [1] 323317 0
Diagnosis / Prognosis
Intervention code [2] 323318 0
Early detection / Screening
Comparator / control treatment
No control group will be used on this trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331001 0
Retention rate (number of patients completing the study /number of patients enrolled) and reasons for discontinuing the study before completion.

This information will determine feasibility for a larger multicentre trial
This data will be collected via audit of study records
Timepoint [1] 331001 0
at completion of the trial
Secondary outcome [1] 408454 0
Number of patients with cardiac uptake at [68Ga]Ga-FAPI PET/CT deemed diagnostic by study criteria

This information will determine if [68Ga]Ga-FAPI is a more effective agent in diagnosing cardiac sarcoidosis.
Timepoint [1] 408454 0
24 hours post PET CT

Eligibility
Key inclusion criteria
• Patient age >= 18 years.
• All patients deemed by the Auckland sarcoid multidisciplinary team to have newly diagnosed, confirmed cardiac sarcoid based on histopathological/clinical/imaging data and who have had a CMR and [18F]FDG PET/CT as part of their diagnostic work up.
• Able to give informed consent
• Willing to use effective contraceptive methods for the duration of the study 90 days after receiving the IMP
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• All pts in which the diagnosis could not be confirmed.
• Pts with confirmed disease who have not had [18F]FDG PET CT or CMR
• Patients who have started therapy for cardiac sarcoidosis.
• Patients unable, or unwilling to consent
• females of childbearing potential must have a negative pregnancy test on the day of treatment study initiation). Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
• Breastfeeding mothers

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
Prospective Pilot
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
Date of last participant enrolment
Anticipated
10/02/2025
Actual
Date of last data collection
Anticipated
11/08/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 24709 0
New Zealand
State/province [1] 24709 0

Funding & Sponsors
Funding source category [1] 311177 0
Self funded/Unfunded
Name [1] 311177 0
Country [1] 311177 0
Primary sponsor type
Commercial sector/Industry
Name
Mercy Radiology
Address
98 Mountain Road, Epsom, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 312537 0
None
Name [1] 312537 0
Address [1] 312537 0
Country [1] 312537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310708 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310708 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 310708 0
New Zealand
Date submitted for ethics approval [1] 310708 0
09/05/2022
Approval date [1] 310708 0
17/10/2022
Ethics approval number [1] 310708 0
2022 FULL 12530

Summary
Brief summary
Myocardial involvement by sarcoid is a rare, but life-threatening manifestation of the disease. Current major criteria for diagnosis include cardiac magnetic resonance imaging to detect scarring and [18F]FDG PET/CT to detect inflammation. [18F]FDG PET/CT for cardiac sarcoidosis is complex, involves arduous preparation for the patient and can carry extra risks and the results of may be inconclusive.

[68Ga]FAPI (fibroblast activating protein inhibitor) is a new agent developed for cancer imaging at PET/CT, but has been shown to detect other conditions including heart disease. Siebermair et al (2021), reported increased cardiac uptake in oncology patients with a known history of myocardial infarction, coronary artery disease and left ventricular failure. If [68Ga]-FAPI PET/CT proves to be more sensitive and specific than [18F] FDG PET CT for diagnosing and quantifying the disease and monitoring response, it will also improve the ease of imaging and has a lower radiation burden.

Although patients may not directly benefit from this pilot study, there may be significant benefit for future patients who require imaging for Sarcoid Heart disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118590 0
Dr Andrew Henderson
Address 118590 0
Mercy Radiology
98 Mountain Road,
Epsom,
Auckland
1023
Country 118590 0
New Zealand
Phone 118590 0
+6402040926652
Fax 118590 0
Email 118590 0
ahenderson@radiology.co.nz
Contact person for public queries
Name 118591 0
Mrs Rosane Joseph
Address 118591 0
Mercy Radiology
98 Mountain Road,
Epsom,
Auckland
1023
Country 118591 0
New Zealand
Phone 118591 0
+64096302234
Fax 118591 0
Email 118591 0
rjoseph@radiology.co.nz
Contact person for scientific queries
Name 118592 0
Dr Andrew Henderson
Address 118592 0
Mercy Radiology
98 Mountain Road,
Epsom,
Auckland
1023
Country 118592 0
New Zealand
Phone 118592 0
+6402040926652
Fax 118592 0
Email 118592 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.