Low-dose CT Enterography for Pediatric Crohn’s Disease Diagnosis and Staging
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-003394
Sponsor Protocol Number: 16-003394
About this study
The study will estimate observer performance for Low-dose CT enterography ( LD-CTE) for detection of ileal inflammation due to Crohn’s disease. It will also determine if an LD-CTE technique using multi-step kV selection and automatic exposure control can routinely acquire volumetric datasets at radiation doses similar to or less than annual background radiation levels. Furthermore, the study will determine if LD-CTE with or without ileocolonoscopy is better than validated patient symptom scores (using the Short Pediatric Crohn’s Disease Activity Index, short PDAI) in identifying patients with moderate to severe ileocolic Crohn’s disease who may benefit from treatment with biologic agents.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Known or suspected Crohn’s disease
- CT enterography ordered by gastroenterologist for clinical purposes
- Scheduled ileocolonoscopy
- Informed consent and short pediatric Crohn’s Disease Index of Activity (Appendix 1) completed
- A negative pregnancy test is required, if the subject is a female of child bearing potential
Exclusion Criteria:
- A female subject with a positive pregnancy test will be excluded.
- Inability to raise hands above head, which would increase the radiation output of the CT scanner using automatic exposure control.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Joel Fletcher, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available