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Completed

NCT Number: NCT02117115

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

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.

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Key information

Conditions

Myelodysplastic Syndromes Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myelogenous, Chronic Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphoproliferative Disorders Multiple Myeloma Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dynamic contrast-enhanced computed tomography

Radiation

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

Other names: CT scan with contrast

Ioversol

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.

Other names: Optiray-350

Primary outcomes

  1. Incidence of contrast related nephropathy

    Time frame: 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.

  2. Incidence of contrast allergic reaction

    Time frame: 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 outcomes

  1. Correlation between CT risk scores and occurrence of acute GVHD

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Early Post-transplant Contrast-enhanced Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation

Acronym: GVHD

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Apr 17, 2014
Registry last updated
Jun 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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