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

Early Phase 1CompletedNCT02117115

Washington University School of Medicine21 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

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

Interventions

Dynamic contrast-enhanced computed tomographyRADIATION

CT scan performed between Day +7 and Day +14.

IoversolDRUG

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Within 4 hours after contrast administration

Secondary Outcomes

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.

Time frame: 180 days