Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001048471
Ethics application status
Approved
Date submitted
28/07/2025
Date registered
23/09/2025
Date last updated
23/09/2025
Date data sharing statement initially provided
23/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study in fibroblast activation factor expression in lung graft versus host disease (GVHD) following haematopoietic stem cell transplant (HSCT)
Scientific title
Utility of 68Ga-FAPI PET Assessment of Pulmonary Chronic Graft Versus Host Disease (PACH-68) in adult allogeneic HSCT recipients
Secondary ID [1] 315007 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Graft Versus Host Disease 338342 0
Condition category
Condition code
Cancer 334634 334634 0 0
Leukaemia - Acute leukaemia
Cancer 334635 334635 0 0
Leukaemia - Chronic leukaemia
Cancer 334636 334636 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 334637 334637 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Inflammatory and Immune System 334843 334843 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single arm design.
All enrolled participants will receive a single dose of 68Ga-Fibroblast Activating Protein Inhibitor (68-Ga-FAPI) via intravenous injection at a dose of 200 MBq to facilitate a single timepoint positron emission tomography (PET) scan at a tertiary hospital or qualified investigative imaging facility by trained experienced staff. PET scans will take approximately 60 minutes to perform.
All enrolled patients will additionally have 50mL of venous blood collected for correlative analysis of blood biomarkers on cannulation for the described 68Ga-FAPI PET scan to minimise discomfort.
Intervention code [1] 331602 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342320 0
Early identification of Pulmonary Graft Versus Host Disease.
Timepoint [1] 342320 0
Single timepoint scan.
Secondary outcome [1] 450311 0
Comparison of utility of diagnosis of Pulmonary Graft Versus Host Disease versus high resolution computed topography (CT) chest scans.
Timepoint [1] 450311 0
CT scans will be conducted on the same day as the exploratory PET.
Secondary outcome [2] 450973 0
Comparison of Pulmonary Graft Versus Host Disease via symptom scoring.
Timepoint [2] 450973 0
At time of data analysis following scan acquisition - with all scans to be interpreted simultaneously at conclusion of enrollment.

Eligibility
Key inclusion criteria
Adult (18 years or older) allogeneic HSCT recipients at Royal Brisbane and Women's Hospital (RBWH), with an existing diagnosis of pulmonary cGVHD (bronchiolitis obliterans syndrome [BOS], cryptogenic organising pneumonia [COP], interstitial lung disease [ILD]).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to lie flat for up to one hour during the imaging procedure

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
1/10/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319572 0
Charities/Societies/Foundations
Name [1] 319572 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 319572 0
Australia
Primary sponsor type
Government body
Name
Metro North
Address
Country
Australia
Secondary sponsor category [1] 322065 0
None
Name [1] 322065 0
Address [1] 322065 0
Country [1] 322065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318135 0
Metro North Health Human Research Ethics Committee
Ethics committee address [1] 318135 0
Ethics committee country [1] 318135 0
Australia
Date submitted for ethics approval [1] 318135 0
19/02/2025
Approval date [1] 318135 0
24/07/2025
Ethics approval number [1] 318135 0
HREC/2025/MNH/115128

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

Contacts
Principal investigator
Name 143226 0
Dr Ross Lindell-Innes
Address 143226 0
Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Queensland , 4006
Country 143226 0
Australia
Phone 143226 0
+61 07 3646 1340
Fax 143226 0
Email 143226 0
[email protected]
Contact person for public queries
Name 143227 0
Ross Lindell-Innes
Address 143227 0
Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Queensland, 4006
Country 143227 0
Australia
Phone 143227 0
+61 07 3646 8111
Fax 143227 0
Email 143227 0
[email protected]
Contact person for scientific queries
Name 143228 0
Ross Lindell-Innes
Address 143228 0
Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Queensland, 4006
Country 143228 0
Australia
Phone 143228 0
+61 07 3646 8111
Fax 143228 0
Email 143228 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.