None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate whether 18FGE-180-Positron Emission Tomography (PET) scans can predict response to steroid treatment for acute gastrointestinal graft versus host disease (GI-GVHD) following haematopoietic progenitor cell transplantation (HPCT) for a haematological cancer. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over and have been referred for diagnostic endoscopy within the previous 7 days for suspected GI-GVHD following HPCT in the previous 100 days for a haematological cancer. Study details All participants enrolled in this trial will receive standard treatment for their condition. In addition, they will all receive two 18FGE-180-PET scans at enrolment (within 7 days of referral for endoscopy) and another scan 7-14 days after the first. The scans will last approximately 30 minutes and will involve receiving an intravenous injection of 18FGE-180 waiting 60 minutes and then proceeding to have a PET/MRI of 30 minutes duration. Researchers will compare the results of these scans to results of the endoscopy procedure by reviewing each patient's medical records. It is hoped that the findings from this trial will provide information on whether 18FGE-180-PET may be useful for predicting response to steroid treatment in these patients
Interventions
Participants will undergo 18FGE-180-Positron Emission Tomography scan at the Herston Imaging Research Facility (HIRF) at Time Point 1 (within 7 days of clinically diagnosed Grade II-IV GI-GVHD) and Time Point 2 (7-14 days following the initial scan based on participant and scanner availability).
During the scanning session participants will be required to be present at HIRF for approximately 1.5 hours.
Participants will be required to have 18FGE-180 administered intravenously and wait 60 min
Participants will undergo 18FGE-180-Positron Emission Tomography scan at the Herston Imaging Research Facility (HIRF) at Time Point 1 (within 7 days of clinically diagnosed Grade II-IV GI-GVHD) and Time Point 2 (7-14 days following the initial scan based on participant and scanner availability). During the scanning session participants will be required to be present at HIRF for approximately 1.5 hours. Participants will be required to have 18FGE-180 administered intravenously and wait 60 minutes to allow the tracer to be distributed throughout the body. After 60 minutes the participant will be moved to the PET/MRI scanner and the scan time will be 30 minutes.
Sponsors
Royal Brisbane and Women's Hospital
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
Age > 18 years; Able to give informed consent; New clinically suspected acute gastrointestinal GVHD Grade II-IV, Within 7 days following referral for diagnostic endoscopic procedure; Within 100 days following allogeneic HPCT for haematologic malignancy
Exclusion criteria
Claustrophobia or anxiety preventing patient from completing the imaging procedure; Inability to lie flat for up to one hour during the imaging procedure; Pregnancy; Any person of reproductive potential who is not willing to use appropriate birth control measures, defined as a double barrier method. This applies to the partners of study participants.
Outcome results
None listed