Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Early Post-transplant Contrast-enhanced Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
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Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, Multiple Myeloma

Intervention / Treatment
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* Radiation: Dynamic contrast-enhanced computed tomography
* Drug: Ioversol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT scan with contrast<br> | Radiation: Dynamic contrast-enhanced computed tomography<br>* CT scan performed between Day +7 and Day +14.<br>* Other names: CT scan with contrast;Drug: Ioversol<br>* 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.<br>* Other names: Optiray-350;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Within 4 hours after contrast administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 180 days |