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

NCT ID: NCT01182467

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-09-30

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.

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.

Conditions

Crohn's Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Crohn's disease

Patients will receieve Radiation: PET-CT scan

PET-CT scan

Intervention Type: RADIATION

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

Interventions

PET-CT scan

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

Intervention Type: RADIATION

Other Intervention Names

Positron emission tomography-computed tomography

Eligibility Criteria

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arun Swaminath, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Masanori Ichise, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAE8300

Identifier Type: -

Identifier Source: org_study_id