Myelodysplastic SyndromesEarly Phase 1GVHDNCT02117115
Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
A Early Phase 1 study testing Dynamic contrast-enhanced computed tomography and Ioversol in people with Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell transplant, and radiographic evidence of mucosal inflammation will be correlated with the subsequent development of acute graft versus host disease. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic
- What is being tested?
- Dynamic contrast-enhanced computed tomography and Ioversol
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2015
- Phase
- Early Phase 1
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Biopsy-proven diagnosis of a hematologic malignancy
- Scheduled to undergo allogeneic SCT from a matched sibling donor or an unrelated donor who is 10/10 or 9/10 HLA match. Transplant eligibility is per standard and institutional criteria.
- Age 18-60 years
- Willing and able to provide informed consent
- -Both men and women and members of all races and ethnic groups are eligible for this trial.
Who cannot join
- Documented or reported contrast allergy
- Estimated glomerular filtration rate (GFR) < 60
- Deemed too sick by clinician to leave the floor for imaging
- "Nothing-per-mouth" status for other clinical reasons
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Early Post-transplant Contrast-enhanced Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell transplant, and radiographic evidence of mucosal inflammation will be correlated with the subsequent development of acute graft versus host disease. The primary endpoint is the feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period, as defined by the risk of contrast-related nephropathy or allergic reaction.
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, Multiple Myeloma
- Being tested
- Dynamic contrast-enhanced computed tomography, Ioversol
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic contrast-enhanced computed tomographyRadiation
Also called CT scan with contrast
CT scan performed between Day +7 and Day +14.
IoversolDrug
Also called Optiray-350
To optimize visualization of bowel mucosal, patient will be given 1350 ml, or as much as can be tolerated, of negative oral contrast to distend the small bowel one hour prior to scanning. A weight-based volume of Optiray-350 will be injected at a rate of 4 cc/sec followed by 50 cc of saline flush also at 4 cc/sec.
| Study group | Role | What they receive |
|---|---|---|
| CT scan with contrast | Experimental | Not described Receives: Radiation: Dynamic contrast-enhanced computed tomography; Drug: Ioversol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast related nephropathy
Contrast related nephropathy is defined as >25% increase in serum creatinine from baseline (day of CT) or 0.5 mg/dL increase in absolute value, within 48-72 hours of intravenous contrast administration.
Assessed using the National Cancer Institute Common Criteria for Adverse Events (NCI CTCAE) Version 4.0.
The proportion of patients who develop contrast nephropathy will be recorded.
Measured: Baseline through 72 hours after intravenous contrast administration
Incidence of contrast allergic reaction
Assessed using the National Cancer Institute Common Criteria for Adverse Events (NCI CTCAE) Version 4.0.
The proportion of patients who an allergic reaction will be recorded.
Measured: Within 4 hours after contrast administration
Secondary outcomes (1)
Correlation between CT risk scores and occurrence of acute GVHD
Images will be reviewed for presence of abnormal mucosal enhancement along the gastrointestinal tract including gallbladder and biliary system, bowel wall thickening, engorgement of vasa recta, mesenteric edema, mesenteric lymphadenopathy, bowel wall thickening, and periportal edema. Abnormal GI mucosal enhancement, if present, will be characterized by relative intensity (mild, moderate, severe), number of involved segments (single segment, two segments, or three segments or more), and location of involved segments. Other findings listed above will provide binary data. All data points will then be used for patient risk stratification for developing GvHD.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Cashen, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117115
- Sponsor's protocol ID
- 201404063
- Acronym
- GVHD
- Status last verified
- Jun 2015
- First submitted
- 15 Apr 2014
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Post-transplant Contrast-enhanced Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02117115
- Acronym / sponsor ID
- GVHD / 201404063
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Apr 2014 (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.
Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell transplant, and radiographic evidence of mucosal inflammation will be correlated with the subsequent development of acute graft versus host disease. The primary endpoint is the feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period, as defined by the risk of contrast-related nephropathy or allergic reaction.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scan with contrast | Experimental | Radiation: Dynamic contrast-enhanced computed tomography, Drug: Ioversol |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Biopsy-proven diagnosis of a hematologic malignancy
- Scheduled to undergo allogeneic SCT from a matched sibling donor or an unrelated donor who is 10/10 or 9/10 HLA match. Transplant eligibility is per standard and institutional criteria.
- Age 18-60 years
- Willing and able to provide informed consent
- -Both men and women and members of all races and ethnic groups are eligible for this trial.
Key exclusion criteria (4 listed)
- Documented or reported contrast allergy
- Estimated glomerular filtration rate (GFR) < 60
- Deemed too sick by clinician to leave the floor for imaging
- "Nothing-per-mouth" status for other clinical reasons
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 |
|---|---|---|
| Dynamic contrast-enhanced computed tomographyAlso: CT scan with contrastCT scan performed between Day +7 and Day +14. | Radiation | CT scan with contrast |
| IoversolAlso: Optiray-350To optimize visualization of bowel mucosal, patient will be given 1350 ml, or as much as can be tolerated, of negative oral contrast to distend the small bowel one hour prior to scanning. A weight-based volume of Optiray-350 will be injected at a rate of 4 cc/sec followed by 50 cc of saline flush also at 4 cc/sec. | Drug | CT scan with contrast |
Primary outcome
Incidence of contrast related nephropathy
Time frame: Baseline through 72 hours after intravenous contrast administration
Contrast related nephropathy is defined as >25% increase in serum creatinine from baseline (day of CT) or 0.5 mg/dL increase in absolute value, within 48-72 hours of intravenous contrast administration. Assessed using the National Cancer Institute Common Criteria for Adverse Events (NCI CTCAE) Version 4.0. The proportion of patients who develop contrast nephropathy will be recorded.
Incidence of contrast allergic reaction
Time frame: Within 4 hours after contrast administration
Assessed using the National Cancer Institute Common Criteria for Adverse Events (NCI CTCAE) Version 4.0. The proportion of patients who an allergic reaction will be recorded.
1 secondary outcome
Correlation between CT risk scores and occurrence of acute GVHD
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
Amanda Cashen, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dynamic contrast-enhanced computed tomography and Ioversol in people with Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, run by Washington University School of Medicine at 1 site in United States.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jun 2015. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of contrast related nephropathy (time frame: Baseline through 72 hours after intravenous contrast administration). The study lists 2 primary outcomes in all. 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 11 Jun 2015.