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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02117115

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes Leukemia, Myeloid, Acute Leukemia, Myelogenous, Chronic Multiple Myeloma	Radiation: Dynamic contrast-enhanced computed tomography Drug: Ioversol	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

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 Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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