PETCT for Diagnosing and Monitoring Acute GVHD (PETGVHD-001)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01596192
First received: May 8, 2012
Last updated: May 9, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Acute Graft Versus Host Disease
Other: PETCT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Sensitivity and Specificity of 18F-Fluorodeoxyglucose Positron Emission Tomography -Computed Tomography for the Diagnosis and Monitoring of Acute Graft vs. Host Disease

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Change of gut FDG uptake at onset and after treatment with steroids in patients with acute GVHD [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Correlation between blood cytokines level and PETCT results [ Time Frame: At the onset of GVHD (up-tp 6 months post transplantation) and then, after 4 weeks (up-to 7 months from transplantation) ] [ Designated as safety issue: No ]
    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. Cytokines levels will be measured as previously described


Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with acute GVHD
Patients after allogeneic hematopoietic cell transplantation who have developed acute GVHD
Other: PETCT

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.


Detailed Description:

Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation (HCT). Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving allograft from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated grafts. Approximately 20% of the patients will develop the severe variant of the disease and there is a tight association between the severity of GVHD and transplantation-related-mortality. The treatment of GVHD is largely based on high dose steroids regimen which is associated with long term morbidity and mortality. In the subgroup of patients with steroid-refractory or slowly resolving GVHD, there are currently no recommendations on the best timing of tapering down the steroids dose in the case of resolution of the disease, or adding a second line medication, in case of non-resolving or progression of the symptoms.

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. Such increased uptake has been described not only in neoplastic lesions but also in inflammatory lesions (2). In this condition, uptake has been correlated with local stimulation of tumor necrosis factor, and with monocyte priming and activation. A physiologic variable uptake may be observed in the bowel, especially the cecum, and has limited the use of PET in inflammatory bowel diseases. The advantage of combined PET and CT devices leads to significant improvements in the interpretation of the bowel areas, and greatly reduces the number of false-positive findings in the gastrointestinal tract.

CT-PET has been recently evaluated in our center as a diagnostic tool for Crohn disease. In this study, CT-PET had a good correlation between FDG uptake and the severity of Crohn disease. In the acute GVHD setting, a study reported on a small cohort suggested a correlation between CT-PET findings, FDG uptake, and the diagnosis of lower gut acute GVHD.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to the BMT unit, Beilinson Hospital with the diagsnosis of acute GVHD

Criteria

Inclusion Criteria:

  1. Patients diagnosed with grade 2-4 acute GVHD
  2. Age> 18 years
  3. Signing an informed consent

Exclusion Criteria:

  1. Men or women less than 18 years of age
  2. Severe Hyperglycemia (>500 mg/dL)
  3. Severe allergy to iodine contrast
  4. Extremely sick patients who cannot be transported to the PET unit
  5. Unable to sign informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596192

Contacts
Contact: Ron Ram, M.D. 97239378116 ronra@clalit.org.il
Contact: Ron Ram, M.D. 972-0504065621 ronra@clalit.org.il

Locations
Israel
BMT unit, Rabin Medical Center, Beilinson Hospital Not yet recruiting
Petah-Tiqva, Israel, 49100
Contact: Ron Ram, M.D.    972-3-9378116    ronra@clalit.org.il   
Principal Investigator: Ron Ram, M.D.         
Sub-Investigator: Moshe Yeshurun, M.D.         
Sub-Investigator: Hanna Bernstine, M.D.         
Sub-Investigator: David Groshar, M.D.         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Ron Ram, M.D. BMT Unit, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01596192     History of Changes
Other Study ID Numbers: RMC-PETGVHD-001
Study First Received: May 8, 2012
Last Updated: May 9, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
allogeneic transplantation, GVHD
Patients with acute GVHD after allogeneic hematopoietic cell transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014