Use of PET-CT in the Management of Crohn's Disease

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. Identifier: NCT01182467
Recruitment Status : Terminated (PI left the institution)
First Posted : August 16, 2010
Last Update Posted : April 10, 2015
Information provided by (Responsible Party):
Columbia University

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.

Condition or disease Intervention/treatment
Crohn's Disease Radiation: PET-CT scan

Detailed Description:

Crohn's disease (CD) is a gastrointestinal autoimmune disease thought to result from exposure to luminal antigen. This exposure then results in a robust Th1 mediated immune response which is not downregulated, resulting in intestinal tissue injury. Crohn's disease most commonly involves the distal small intestine, a site that can be difficult to visualize given its central location within the gastrointestinal tract.

A substantial proportion of patients do not respond to any of the standard therapies. Over 40% of patients do not respond to an initial anti-TNF (biologic) agent and approximately 10% per year lose their response to these drugs. There is no standard definition of what constitutes a patient who has primary biologic failure.

Disease activity is measured by indices such as the Crohn's Disease Activity Index (CDAI). The CDAI includes a combination of clinical criteria and lab values. However, the CDAI is limited by reliance on subjective criteria, limiting the score's use as a valid measure of studying response to medical therapy. Clinically, reliance on CDAI can result in inappropriate continuation of an ineffective therapy resulting in worsening of underlying disease, and increasing risk of adverse reactions.

Small studies have demonstrated that PET scans may accurately quantify disease activity in Crohn's. We propose to study CD patients with active flares to assess for a correlation between PET activity and CDAI. Additionally, we will determine whether PET signal intensity is predictive of clinical response to therapy with biologic agents.

The study proposes to test the hypothesis that PET can be used to determine which CD patients with small bowel disease will be true responders (or nonresponders) to biologic therapy at week 12. The use of PET to determine response to biologic therapy in small bowel Crohn's disease would be novel.

Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study in the Use of Positron Emission Tomography-Computed Tomography (PET-CT)in the Management of Crohn's Disease
Study Start Date : February 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Crohn's disease
Patients will receieve Radiation: PET-CT scan
Radiation: PET-CT scan
PET-CT scan performed at baseline to determine SUV-max
Other Name: Positron emission tomography-computed tomography

Primary Outcome Measures :
  1. Pravelence of PET activity with high CDAI score. [ Time Frame: Baseline ]
    To determine whether baseline PET SUV-max correlates with response to biologic therapy, as measure by CDAI.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adults between ages of 21-65 who have previously been diagnosed with Crohn's disease

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

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 identifier (NCT number): NCT01182467

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: Arun Swaminath, MD Columbia University
Principal Investigator: Masanori Ichise, MD Columbia University

Responsible Party: Columbia University Identifier: NCT01182467     History of Changes
Other Study ID Numbers: AAAE8300
First Posted: August 16, 2010    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Columbia University:
Inflammatory bowel disease, PET scan, Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases