Back to resultsAbdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (GVHD)
Primary Purpose
Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dynamic contrast-enhanced computed tomography
Ioversol
Sponsored by
About this trial
This is an interventional screening trial for Myelodysplastic Syndromes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Inclusion of Women and Minorities
-Both men and women and members of all races and ethnic groups are eligible for this trial.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT scan with contrast
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02117115
First Posted
April 15, 2014
Last Updated
June 10, 2015
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02117115
Brief Title
Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Acronym
GVHD
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, Multiple Myeloma
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT scan with contrast
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Dynamic contrast-enhanced computed tomography
Other Intervention Name(s)
CT scan with contrast
Intervention Description
CT scan performed between Day +7 and Day +14.
Intervention Type
Drug
Intervention Name(s)
Ioversol
Other Intervention Name(s)
Optiray-350
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of contrast related nephropathy
Description
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.
Time Frame
Baseline through 72 hours after intravenous contrast administration
Title
Incidence of contrast allergic reaction
Description
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.
Time Frame
Within 4 hours after contrast administration
Secondary Outcome Measure Information:
Title
Correlation between CT risk scores and occurrence of acute GVHD
Description
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.
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Inclusion of Women and Minorities
-Both men and women and members of all races and ethnic groups are eligible for this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Cashen, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
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