NCT01182467

Brief Summary

Crohn's disease (CD) is an autoimmune disorder which affects over 700,000 people in the U.S. The disease can vary in severity and multiple drug classes are available to the disease depending on disease severity and complications. Our purpose will be to study how PET-CT scans can be used to better manage Crohn's Disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

August 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

August 12, 2010

Last Update Submit

April 9, 2015

Conditions

Crohn's Disease

Keywords

Inflammatory bowel disease, PET scan, Crohn's disease

Outcome Measures

Primary Outcomes (1)

  • Pravelence of PET activity with high CDAI score.

    To determine whether baseline PET SUV-max correlates with response to biologic therapy, as measure by CDAI.

    Baseline

Study Arms (1)

Crohn's disease

Patients will receieve Radiation: PET-CT scan

Radiation: PET-CT scan

Interventions

PET-CT scanRADIATION

PET-CT scan performed at baseline to determine SUV-max

Also known as: Positron emission tomography-computed tomography
Crohn's disease

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults between ages of 21-65 who have previously been diagnosed with Crohn's disease

You may qualify if:

  • Diagnosis of Crohn's disease
  • CDAI1\>220
  • Identification of small bowel disease based on an imaging study (CT scan, Abdominal ultrasound, MRI), colonoscopy, or histopathology 4. Need for initiation of biologic therapy to control disease process.

You may not qualify if:

  • Abdominal surgery within 8 wks of study entry
  • Change in dose of steroids or immunomodulators within 2wks of study entry
  • Pregnancy
  • Active bacterial infection or undrained abscess
  • Any contraindications to initiation of AntiTNF therapy (i.e. latent tuberculosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Arun Swaminath, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Masanori Ichise, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2010

First Posted

August 16, 2010

Study Start

February 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

US(1)