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

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The Washington University

Status and phase

Completed
Early Phase 1

Conditions

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

Treatments

Radiation: Dynamic contrast-enhanced computed tomography
Drug: Ioversol

Study type

Interventional

Funder types

Other

Identifiers

NCT02117115
201404063

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No 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

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

CT scan with contrast
Experimental group
Treatment:
Drug: Ioversol
Radiation: Dynamic contrast-enhanced computed tomography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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