None listed
Conditions
Brief summary
This study aims to assess if it is feasible and accurate to use a novel PET scan to identify pulmonary Graft Versus Host Disease (GVHD) following haematopoietic stem cell transplant (HSCT) for blood cancers earlier than conventional and invasive testing. Who is it for? You may be eligible for this study if you are an adult allogeneic HSCT recipient at Royal Brisbane and Women's Hospital, with an existing diagnosis of pulmonary cGVHD (bronchiolitis obliterans syndrome [BOS], cryptogenic organising pneumonia [COP], or interstitial lung disease [ILD]). Study details Participants will undergo a single 68-Ga Fibroblast Activating Protein Inhibitor (FAPI) scan, as well as other testing modalities such as spirometry, high resolution CT scan and clinical questionnaires. These modalities will be compared against each other to determine the ability of the FAPI PET scan to detect lung scarring in pulmonary GVHD. It is hoped that findings from this study will help researchers develop new and less invasive ways to detect pulmonary GVHD to facilitate earlier management and intervention.
Interventions
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
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.
Sponsors
Metro North
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
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]).
Exclusion criteria
Inability to lie flat for up to one hour during the imaging procedure
Outcome results
None listed