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Trial registered on ANZCTR


Registration number
ACTRN12617000933358
Ethics application status
Approved
Date submitted
21/06/2017
Date registered
27/06/2017
Date last updated
27/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
18FGE-180-Positron Emission Tomography in Graft Versus Host Disease
Scientific title
Pilot study to evaluate the feasibility of 18FGE-180-Postiron Emission Tomography to assess acute gastrointestinal graft versus host disease.
Secondary ID [1] 292248 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Graft Versus Host Disease 303750 0
Haematological Cancer 303751 0
Condition category
Condition code
Oral and Gastrointestinal 303123 303123 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 303158 303158 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298413 0
Diagnosis / Prognosis
Comparator / control treatment
A Gut biopsy is part of the standard of care clinical management of patients diagnosed with GVHD at the RBWH. The gut biopsy will occur prior to project consent and enrolment as part of GVHD diagnostic procedures. Participants who consent to the project will have their Gut Biopsy results compared to the PET/MRI as part of the project analysis.
Control group
Active

Outcomes
Primary outcome [1] 302503 0
Feasibility of the 18FGE-180-Positron Emission Tomography imaging protocol, assessed by proportion of participants in whom imaging findings are documented in the medical records
Timepoint [1] 302503 0
At time of first scan post GVHD diagnosis and pre-GVHD treatment.
Secondary outcome [1] 336247 0
Examining the difference between the 18FGE-180-Positron Emission Tomography imaging results from time point 1 (diagnosis) to time point 2 (following initiation of steroid therapy for Gastrointestinal-Graft Versus Host Disease) as reported by a qualified Nuclear Medicine Specialist and Radiologist.
Timepoint [1] 336247 0
7 -14 Days post Graft Versus Host Disease Treatment initiation.
Secondary outcome [2] 336248 0
Correlation between 18FGE-180-PET results and histological staging from gut biopsy.
Timepoint [2] 336248 0
Scan performed at diagnosis, gut biopsy performed prior to diagnosis per standard care.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/08/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8413 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 16485 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 296795 0
Charities/Societies/Foundations
Name [1] 296795 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 296795 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
Herston Queensland Australia 4006
Country
Australia
Secondary sponsor category [1] 295781 0
None
Name [1] 295781 0
Address [1] 295781 0
Country [1] 295781 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298030 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 298030 0
Level 7 Block 7
Herston Road
Queensland Australia 4029
Ethics committee country [1] 298030 0
Australia
Date submitted for ethics approval [1] 298030 0
24/04/2017
Approval date [1] 298030 0
12/06/2017
Ethics approval number [1] 298030 0
HREC/17/QRBW/216

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75750 0
Dr Ashleigh Scott
Address 75750 0
Cancer Care Services
Level 5 Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield Street Herston Queensland 4006
Country 75750 0
Australia
Phone 75750 0
+61 7 3646 8111
Fax 75750 0
Email 75750 0
[email protected]
Contact person for public queries
Name 75751 0
Ashleigh Scott
Address 75751 0
Cancer Care Services
Level 5 Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield Street Herston Queensland 4006
Country 75751 0
Australia
Phone 75751 0
+61 7 3646 8111
Fax 75751 0
Email 75751 0
[email protected]
Contact person for scientific queries
Name 75752 0
Ashleigh Scott
Address 75752 0
Cancer Care Services
Level 5 Joyce Tweddell Building
Royal Brisbane and Women's Hospital
Butterfield Street Herston Queensland 4006
Country 75752 0
Australia
Phone 75752 0
+61 7 3646 8111
Fax 75752 0
Email 75752 0
[email protected]

No information has been provided regarding IPD availability


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.