Acute Graft Versus Host DiseasePETGVHD-001NCT01596192
PETCT for Diagnosing and Monitoring Acute GVHD
An observational study of Acute Graft Versus Host Disease, run by Rabin Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Graft Versus Host Disease
- What is being tested?
- PETCT
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the BMT unit, Beilinson Hospital with the diagsnosis of acute GVHD
Who may be able to join
- Patients diagnosed with grade 2-4 acute GVHD
- Age> 18 years
- Signing an informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
BMT unit, Rabin Medical Center, Beilinson Hospital
Petah Tikva, 49100
Ron Ram, M.D., 972-3-9378116, ronra@clalit.org.il
Ron Ram, M.D.
About this study
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
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.
Read the 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.
- Conditions
- Acute Graft Versus Host Disease
- Being tested
- PETCT
- Keywords
- allogeneic transplantation, GVHD, Patients with acute GVHD after allogeneic hematopoietic cell transplantation
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETCTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute GVHD | Patients after allogeneic hematopoietic cell transplantation who have developed acute GVHD Receives: Other: PETCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: At the onset of GVHD (up-tp 6 months post transplantation) and then, after 4 weeks (up-to 7 months from transplantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Ram, M.D., Principal investigator, BMT Unit, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596192
- Sponsor's protocol ID
- RMC-PETGVHD-001
- Acronym
- PETGVHD-001
- Status last verified
- Feb 2012
- First submitted
- 8 May 2012
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01596192
- Acronym / sponsor ID
- PETGVHD-001 / RMC-PETGVHD-001
- Conditions
- Acute Graft Versus Host Disease
- Keywords
- allogeneic transplantation, GVHD, Patients with acute GVHD after allogeneic hematopoietic cell transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute GVHD | – | Other: PETCTPatients after allogeneic hematopoietic cell transplantation who have developed acute GVHD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the BMT unit, Beilinson Hospital with the diagsnosis of acute GVHD
Key inclusion criteria (3 listed)
- Patients diagnosed with grade 2-4 acute GVHD
- Age> 18 years
- Signing an informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PETCTCT-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. | Other | Patients with acute GVHD |
Primary outcome
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)
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.
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Ram, M.D. principal investigator
BMT Unit, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Graft Versus Host Disease, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ron Ram, M.D. (97239378116, ronra@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.