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

NCT ID: NCT02117115

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-05-31

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.

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic; Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

CT scan with contrast

Group Type: EXPERIMENTAL

Dynamic contrast-enhanced computed tomography

Intervention Type: RADIATION

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

Ioversol

Intervention Type: DRUG

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.

Interventions

Dynamic contrast-enhanced computed tomography

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

Intervention Type: RADIATION

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.

Intervention Type: DRUG

Other Intervention Names

CT scan with contrast; Optiray-350

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Cashen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

201404063

Identifier Type: -

Identifier Source: org_study_id