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

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.

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Multiple Myeloma; Leukemia, Myelogenous, Chronic
• Intervention / Treatment: Radiation: Dynamic contrast-enhanced computed tomography; Drug: Ioversol

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CT scan with contrast

Radiation: Dynamic contrast-enhanced computed tomography; CT scan performed between Day +7 and Day +14.; Other Names: CT scan with contrast; Drug: Ioversol; 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.; Other Names: Optiray-350

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 16, 2014
• First Posted (Estimate): April 17, 2014

Study Record Updates

• Last Update Posted (Estimate): June 11, 2015
• Last Update Submitted That Met QC Criteria: June 10, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Myeloproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Myelodysplastic Syndromes; Multiple Myeloma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Graft vs Host Disease
• Other Study ID Numbers: 201404063