Trials / Completed
CompletedNCT02117115
Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Early Post-transplant Contrast-enhanced Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 20 Years – 60 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2014-10-01
- Completion
- 2015-05-01
- First posted
- 2014-04-17
- Last updated
- 2015-06-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02117115. Inclusion in this directory is not an endorsement.