Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117115
Recruitment Status : Completed
First Posted : April 17, 2014
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Leukemia, Myeloid, Acute Leukemia, Myelogenous, Chronic Multiple Myeloma Radiation: Dynamic contrast-enhanced computed tomography Drug: Ioversol Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Early Post-transplant Contrast-enhanced Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Study Start Date : June 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Experimental: CT scan with contrast Radiation: Dynamic contrast-enhanced computed tomography
CT scan performed between Day +7 and Day +14.
Other Name: CT scan with contrast

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.
Other Name: Optiray-350




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117115


Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Amanda Cashen, M.D. Washington University School of Medicine

Additional Information:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02117115    
Other Study ID Numbers: 201404063
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Multiple Myeloma
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Graft vs Host Disease
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Myeloproliferative Disorders