Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001053819
Ethics application status
Approved
Date submitted
30/09/2012
Date registered
3/10/2012
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the role of Positron Emission Tomography (PET) scanning as a non invasive technique to diagnose graft vs host disease of the gastrointestinal tract following bone marrow transplantation.
Scientific title
A Pilot Study of Non Invasive Assessment of Acute Graft vs Host Disease of the Gastrointestinal Tract and Treatment Response Following Allogeneic Haemopoetic Stem Cell Transplantation using 18F-FDG PET.
Secondary ID [1] 281324 0
Nil
Universal Trial Number (UTN)
U1111-1135-2964
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Graft vs Host Disease of the Gastrointestinal tract following bone marrow transplant. 287540 0
Condition category
Condition code
Blood 287865 287865 0 0
Haematological diseases
Oral and Gastrointestinal 287878 287878 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 287879 287879 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with clinically suspected acute graft vs host disease of the gastrointestinal tract following bone marrow transplantation will have a positron emission tomography (PET) scan to determine whether this non invasive technique is useful to detect the condition. The PET scan takes approximately 30 minutes to complete.
Intervention code [1] 285788 0
Diagnosis / Prognosis
Comparator / control treatment
PET scanning at time of suspected acute graft vs host disease of the gastrointestinal tract will be performed in all participants and compared with biopsy results obtained during conventional investigation with gastrocopy and colonoscopy.
Control group
Active

Outcomes
Primary outcome [1] 288088 0
To assess whether PET scanning accurately detects acute graft vs host disease of the gastrointestinal tract when clinically suspected.
Timepoint [1] 288088 0
PET scan - At time graft vs host disease is clinically suspected
Gastroscopy and Colonoscopy - Within 7 days of PET scan
Secondary outcome [1] 299401 0
NA
Timepoint [1] 299401 0
NA

Eligibility
Key inclusion criteria
Clinical Suspicion of acute Graft vs Host disease of the gastrointestinal tract Day 20-180 post allogeneic bone marrow transplantation
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Commencement of therapy for suspected acute graft vs host disease of the gastrointestinal tract prior to PET scanning

Significant uncontrolled intercurrent illness

Lactating or pregnant

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)
Patients with clinically suspected acute graft vs host disease of the gastrointestinal tract D20-180 post allogeneic bone marrow transplant will be referred by their treating clinician for entry into the study. They will then have a PET scan prior to Gastroscopy and Colonoscopy during which biopsies of the gastrointestinal will be obtained to evaluate whether graft vs host disease is present.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The PET scanner was upgraded to a new one in 2015 hence results on the new PET scanner would not be as comparable with those performed on the original PET scanner potentially affecting accuracy of analysis.
Date of first participant enrolment
Anticipated
6/04/2010
Actual
6/04/2010
Date of last participant enrolment
Anticipated
Actual
27/11/2014
Date of last data collection
Anticipated
Actual
27/11/2014
Sample size
Target
60
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286086 0
Hospital
Name [1] 286086 0
Alfred Hospital
Country [1] 286086 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Alfred Foundation
Address
Alfred Hospital
55 Commercial Road Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 284900 0
None
Name [1] 284900 0
Address [1] 284900 0
Country [1] 284900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288139 0
Alfred Hospital Research and Ethics Committee
Ethics committee address [1] 288139 0
Alfred Hospital
55 Commercial Road Melbourne Victoria 3004
Ethics committee country [1] 288139 0
Australia
Date submitted for ethics approval [1] 288139 0
26/03/2009
Approval date [1] 288139 0
31/03/2009
Ethics approval number [1] 288139 0
57/09

Summary
Brief summary
The study is evaluating whether a diagnostic technique, known as PET scanning, can provide a non invasive means of evaluating the presence of acute graft vs host disease of the gastrointestinal tract following bone marrow transplantation.

Who is it for?
You may be eligible to join this study if you are aged above 18 years and have suspected acute graft vs host disease of the gastrointestinal tract following bone marrow transplantation.

Trial details
All participants in this trial will undergo a positron emission tomography (PET) scan at the time acute graft vs host disease of the gastrointestinal tract is suspected. A PET scan involves injection of a small amount of radioactive tracer into the bloodstream followed by scanning of the whole body in a machine that looks similar to a CT scan machine for approximately 30 minutes.

In addition, participants will undergo standard care, which involves a gastroscopy and colonoscopy where biopsies of the gastrointestinal tract are obtained to assess whether graft vs host disease is present or not.

This study will help us to determine whether PET scanning can accurately assess non invasively the presence of acute graft vs host disease of the gastrointestinal tract following bone marrow transplantation.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 34777 0
Dr Martin Cherk
Address 34777 0
Dept of Nuclear Medicine
Alfred Hospital
55 Commercial Rd
Melbourne Victoria 3004
Country 34777 0
Australia
Phone 34777 0
61 3 90762432
Fax 34777 0
Email 34777 0
[email protected]
Contact person for public queries
Name 18024 0
Dr Dr Martin Cherk
Address 18024 0
Dept of Nuclear Medicine
Alfred Hospital
55 Commercial Road Melbourne Victoria 3004
Country 18024 0
Australia
Phone 18024 0
+61 3 90762432
Fax 18024 0
+61 3 90762599
Email 18024 0
[email protected]
Contact person for scientific queries
Name 8952 0
Dr Dr Martin Cherk
Address 8952 0
Dept of Nuclear Medicine
Alfred Hospital
55 Commercial Road Melbourne Victoria 3004
Country 8952 0
Australia
Phone 8952 0
+61 3 90762432
Fax 8952 0
+61 3 90762599
Email 8952 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.