Crohn's DiseasePhase 4NCT00731809
Evaluation of PET CT in the Management of Patients With Crohn's Disease.
A Phase 4 study testing FDG PET CT in people with Crohn's Disease, run by Rabin Medical Center at 1 site in Israel.
Trial summary
18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- FDG PET CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Oct 2010
- Phase
- Phase 4
- 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
- Patients suspicious for active disease:
- Patients with suspected but undiagnosed Crohn's disease
- Patients with serological markers of inflammation (elevated ESR, CRP or thrombocytosis) but clinically in remission
- Patients with a stricture which might be fibrous in which case surgery is indicated or inflammatory for which medical management is indicated
- Able to sign a consent form
Who cannot join
- Pregnancy
- Breastfeeding
- Infectious colitis determined at the initial checkup
- Allergy to iodine contrast
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva, 49100
Bernstine, MD, hannab2@clalit.org.il
Hanna Bernstine, MD
About this study
18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. Such increased uptake has been described not only in neoplastic lesions but also in inflammatory lesions. In this condition, uptake has been correlated with local stimulation of tumor necrosis factor, and with monocyte priming and activation. A physiologic variable uptake may be observed in the bowel, especially the cecum, and has limited the use of PET in inflammatory bowel diseases. The advantage of combined PET and CT devices lead to significant improvements in the interpretation of the bowel areas, and greatly reduces the number of false-positive findings in the gastrointestinal tract.
- Conditions
- Crohn's Disease
- Being tested
- FDG PET CT
- Keywords
- Crohn's disease
- 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 CTRadiation
FDG PET CT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | PET CT Receives: Radiation: FDG PET CT |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2010 (estimated)
- Study completionOct 2010 (estimated)
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.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731809
- Sponsor's protocol ID
- 004945
- Status last verified
- Feb 2008
- First submitted
- 3 Aug 2008
- Last updated
- 23 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PET CT in the Management of Patients With Crohn's Disease.
- ClinicalTrials.gov ID
- NCT00731809
- Acronym / sponsor ID
- 004945
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 11 Aug 2008 (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.
18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. Such increased uptake has been described not only in neoplastic lesions but also in inflammatory lesions. In this condition, uptake has been correlated with local stimulation of tumor necrosis factor, and with monocyte priming and activation. A physiologic variable uptake may be observed in the bowel, especially the cecum, and has limited the use of PET in inflammatory bowel diseases. The advantage of combined PET and CT devices lead to significant improvements in the interpretation of the bowel areas, and greatly reduces the number of false-positive findings in the gastrointestinal tract.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Radiation: FDG PET CTPET CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suspicious for active disease:
Key exclusion criteria (4 listed)
- Pregnancy
- Breastfeeding
- Infectious colitis determined at the initial checkup
- Allergy to iodine contrast
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 CTFDG PET CT | Radiation | 1 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FDG PET CT in people with Crohn's Disease, run by Rabin Medical Center at 1 site in Israel.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2008. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 23 Dec 2008.