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

Early Phase 1

Completed

• Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic; Multiple Myeloma
• Interventions: Radiation: Dynamic contrast-enhanced computed tomography; Drug: Ioversol

• Registration Number: NCT02117115
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-17
• Study Start: 2014-06
• Primary Completion: 2014-10
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT scan with contrast	Dynamic contrast-enhanced computed tomography	-
CT scan with contrast	Ioversol	-

Primary Outcome Measures

Name	Time	Method
Incidence of contrast related nephropathy	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	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between CT risk scores and occurrence of acute GVHD	180 days	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States