Crohn's DiseaseNCT01182467
Use of PET-CT in the Management of Crohn's Disease
An observational study of Crohn's Disease, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- PET-CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults between ages of 21-65 who have previously been diagnosed with Crohn's disease
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Pilot Study in the Use of Positron Emission Tomography-Computed Tomography (PET-CT)in the Management of Crohn's Disease
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.
Read the 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
- Being tested
- PET-CT scan
- Keywords
- Inflammatory bowel disease, PET scan, Crohn's disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT scanRadiation
Also called Positron emission tomography-computed tomography
PET-CT scan performed at baseline to determine SUV-max
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease | Patients will receieve Radiation: PET-CT scan Receives: Radiation: PET-CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startFeb 2011
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arun Swaminath, MD, Principal investigator, Columbia UniversityMasanori Ichise, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182467
- Sponsor's protocol ID
- AAAE8300
- Status last verified
- Apr 2015
- First submitted
- 12 Aug 2010
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study in the Use of Positron Emission Tomography-Computed Tomography (PET-CT)in the Management of Crohn's Disease
- ClinicalTrials.gov ID
- NCT01182467
- Acronym / sponsor ID
- AAAE8300
- Conditions
- Crohn's Disease
- Keywords
- Inflammatory bowel disease, PET scan, Crohn's disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left the institution
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease | – | Radiation: PET-CT scanPatients will receieve Radiation: PET-CT scan |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults between ages of 21-65 who have previously been diagnosed with Crohn's disease
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-CT scanAlso: Positron emission tomography-computed tomographyPET-CT scan performed at baseline to determine SUV-max | Radiation | Crohn's disease |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Swaminath, MD principal investigator
Columbia University
Masanori Ichise, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pravelence of PET activity with high CDAI score. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.