Crohn DiseasePhase 2NCT00383344
Use of FDG PET/CT to Evaluate Crohn Disease
A Phase 2 study testing FDG PET/CT in people with Crohn Disease, run by Eric Turcotte at 1 site in Canada.
Trial summary
The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn Disease and recurrence of Crohn disease after having compared results of PET/CT's with results of exams routinely performed(colonoscopy and bowel follow through). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- FDG PET/CT
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2006to 1 May 2007
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women known having a Crohn's disease de novo diagnosis or a Crohn's disease recurrence based on a seven days questionnaire and a physical exam.
- Men or women with a past history of Crohn's disease but considered clinically in remission based on a seven days questionnaire, a physical exam and a Crohn's disease activity index (CDAI) score < to 150.
Who cannot join
- Men or women less than 18 years of age
- Pregnancy
- Breastfeeding
- Renal failure
- Suspicion of a Crohn's disease infectious complication (abscess,fistula)
- Infectious colitis determined at the initial checkup
- Diabetes
- Severe allergy to iode contrast
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study on the Role of the Positron Emission Tomography Combined With CT Scan for the Evaluation on Crohn Disease
The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn Disease and recurrence of Crohn disease after having compared results of PET/CT's with results of exams routinely performed(colonoscopy and bowel follow through).
Read the detailed description
Crohn disease is an inflammatory disease of the digestive system that may affect the small and large intestines. Remission and recurrence clinically characterized its development. When recurrence occurs, a careful examination is necessary in order to determine the extent and the severity of the disease. Actual exams performed are invasive and uncomfortable(colonoscopy and bowel follow through). Compare to these exams, PET/CT is less fierce to undergo and has less risks. Two groups are proposed in this project: 15 patients will be enroll in the active disease group and 15 patients will be enroll in the remission group. In regards of the area and the extent of the disease,PET/CT exams shall provide similar information than what usual tests provide. PET/CT exams shall also provide more information in order to better differentiate inflammatory stenosis from scars stenosis especially located in the small intestine.
- Conditions
- Crohn Disease
- Being tested
- FDG PET/CT
- Keywords
- Crohn Disease, Positron Emission Tomography, Colonoscopy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET/CTProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Crohn Disease de novo and Crohn Disease recurrences with FDG PET/CT.
Secondary outcomes (2)
Detection of inflammatory areas not suspected with usual tests
Detection of an inflammatory activity for remission patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study start1 Oct 2006
- Primary completion1 May 2007
- Study completion1 May 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eric Turcotte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Turcotte, Université de Sherbrooke
- Investigators
- François Bénard, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383344
- Sponsor's protocol ID
- 06-086
- Status last verified
- Dec 2024
- First submitted
- 2 Oct 2006
- Last updated
- 9 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on the Role of the Positron Emission Tomography Combined With CT Scan for the Evaluation on Crohn Disease
- ClinicalTrials.gov ID
- NCT00383344
- Acronym / sponsor ID
- 06-086
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Positron Emission Tomography, Colonoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eric TurcotteUniversity, hospital or other
- Study start
- 1 Oct 2006 (actual)
- Primary completion
- 1 May 2007 (actual)
- Study completion
- 1 May 2007 (actual)
- First posted
- 3 Oct 2006 (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.
The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn Disease and recurrence of Crohn disease after having compared results of PET/CT's with results of exams routinely performed(colonoscopy and bowel follow through).
Detailed description
Crohn disease is an inflammatory disease of the digestive system that may affect the small and large intestines. Remission and recurrence clinically characterized its development. When recurrence occurs, a careful examination is necessary in order to determine the extent and the severity of the disease. Actual exams performed are invasive and uncomfortable(colonoscopy and bowel follow through). Compare to these exams, PET/CT is less fierce to undergo and has less risks. Two groups are proposed in this project: 15 patients will be enroll in the active disease group and 15 patients will be enroll in the remission group. In regards of the area and the extent of the disease,PET/CT exams shall provide similar information than what usual tests provide. PET/CT exams shall also provide more information in order to better differentiate inflammatory stenosis from scars stenosis especially located in the small intestine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women known having a Crohn's disease de novo diagnosis or a Crohn's disease recurrence based on a seven days questionnaire and a physical exam.
- Men or women with a past history of Crohn's disease but considered clinically in remission based on a seven days questionnaire, a physical exam and a Crohn's disease activity index (CDAI) score < to 150.
Key exclusion criteria (8 listed)
- Men or women less than 18 years of age
- Pregnancy
- Breastfeeding
- Renal failure
- Suspicion of a Crohn's disease infectious complication (abscess,fistula)
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 |
|---|---|---|
| FDG PET/CT | Procedure or surgery | – |
Primary outcome
Diagnosis of Crohn Disease de novo and Crohn Disease recurrences with FDG PET/CT.
2 secondary outcomes
Detection of inflammatory areas not suspected with usual tests
Detection of an inflammatory activity for remission patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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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.
François Bénard, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FDG PET/CT in people with Crohn Disease, run by Eric Turcotte at 1 site in Canada.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 9 Dec 2024. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnosis of Crohn Disease de novo and Crohn Disease recurrences with FDG PET/CT.. 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 9 Dec 2024.