NCT02117115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 11, 2015

Status Verified

June 1, 2015

Enrollment Period

4 months

First QC Date

April 15, 2014

Last Update Submit

June 10, 2015

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, AcuteLeukemia, Myelogenous, ChronicMultiple Myeloma

Outcome Measures

Primary Outcomes (2)

  • Incidence of contrast related nephropathy

    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.

    Baseline through 72 hours after intravenous contrast administration

  • Incidence of contrast allergic reaction

    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.

    Within 4 hours after contrast administration

Secondary Outcomes (1)

  • Correlation between CT risk scores and occurrence of acute GVHD

    180 days

Study Arms (1)

CT scan with contrast

EXPERIMENTAL
Radiation: Dynamic contrast-enhanced computed tomographyDrug: Ioversol

Interventions

Dynamic contrast-enhanced computed tomographyRADIATION

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

Also known as: CT scan with contrast
CT scan with contrast
IoversolDRUG

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.

Also known as: Optiray-350
CT scan with contrast

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Both men and women and members of all races and ethnic groups are eligible for this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, AcuteLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMultiple Myeloma

Interventions

Contrast Mediaioversol

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Amanda Cashen, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 17, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2014

Study Completion

May 1, 2015

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations

US(1)