PETCT for Diagnosing and Monitoring Acute GVHD
PETGVHD-001
The Sensitivity and Specificity of 18F-Fluorodeoxyglucose Positron Emission Tomography -Computed Tomography for the Diagnosis and Monitoring of Acute Graft vs. Host Disease
1 other identifier
observational
30
1 country
1
Brief Summary
Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation. 18F-FDG PET/CT (2-\[fluorine-18\] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. In this study, we aim to evaluate and characterize the correlation between CT-PET findings in patients suspected to have acute GVHD, and the disease course.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 8, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMay 10, 2012
February 1, 2012
10 months
May 8, 2012
May 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of gut FDG uptake at onset and after treatment with steroids in patients with acute GVHD
CT-PET will be performed at the onset of GVHD(up-to 6 months from transplantation) and repeated after 4 weeks. The findings will be compared with the initial CT-PET results. The time frame of 4 weeks is the period of time in which most patients become either asymptomatic or in need for additional immunosuppressive therapy. In addition, all patients will go through the standard GVHD evaluation practice which includes (but not limited to) GI endoscopy (sigmoidoscopy and/or gastroscopy) and skin biopsies. Data obtained from the CT PET results will be compared with the GI findings.
At the onset of GVHD (up-to 6 months after hematopoietic cell transplantation) and then after 4 weeks from the date of first CT-PET (up-to 7 months after transplantation)
Secondary Outcomes (1)
Correlation between blood cytokines level and PETCT results
At the onset of GVHD (up-tp 6 months post transplantation) and then, after 4 weeks (up-to 7 months from transplantation)
Study Arms (1)
Patients with acute GVHD
Patients after allogeneic hematopoietic cell transplantation who have developed acute GVHD
Interventions
CT-PET will be performed within 3 days from acute GVHD diagnosis. Each patient will receive 400-610 MBq (11-16.5 mCi) of 18F-FDG intravenously. After tracer injection, the patients will rest on a comfortable chair during the 18F-FDG-uptake period, and drink with 150-300mg Levolac (Fresenius Kabi, Austria) diluted in 1000-1500cc water. CT-PET will be initiated 45-50 min after injection of the 18F-FDG.ll scans will be performed on a Discovery STE PET/CT scanner (General Electric Medical Systems, Milwaukee, WI). CT will be performed 45-50 minutes after drinking the diluted lactulose solution had been ingested. The CT images will be acquired from the diaphragm to the symphysis pubis. After IV administration of 100 ml of nonionic contrast medium at a flow rate of 2.5 ml/sec.
Eligibility Criteria
Patients admitted to the BMT unit, Beilinson Hospital with the diagsnosis of acute GVHD
You may qualify if:
- Patients diagnosed with grade 2-4 acute GVHD
- Age\> 18 years
- Signing an informed consent
You may not qualify if:
- Men or women less than 18 years of age
- Severe Hyperglycemia (\>500 mg/dL)
- Severe allergy to iodine contrast
- Extremely sick patients who cannot be transported to the PET unit
- Unable to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BMT unit, Rabin Medical Center, Beilinson Hospital
Petah Tikva, 49100, Israel
Biospecimen
Levels of HGF, IL8, IL2R and TNFR1 will be measured at the onset of GVHD and prior to the second PET-CT. Five cc blood will be drawn twice from each patient and will be collected in an EDTA containing tube.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Ram, M.D.
BMT Unit, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2012
First Posted
May 10, 2012
Study Start
May 1, 2012
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
May 10, 2012
Record last verified: 2012-02