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

NCT02117115 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-06-11

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Dynamic contrast-enhanced computed tomography

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

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Amanda Cashen, M.D. · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-10-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117115 on ClinicalTrials.gov