Inflammatory Bowel DiseasesPhase 4NCT00205062
Positron Emission Tomography (PET)-Computed Tomography (CT) in Inflammatory Bowel Disease (IBD)
A Phase 4 study testing PET-CT in people with Inflammatory Bowel Diseases, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The main hypothesis is that PET-CT will be a valuable diagnostic tool in diagnosing and evaluating treatment for IBD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- PET-CT
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Aug 2008
- 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
- Patient with either Crohn's disease or ulcerative colitis whose disease is flaring
Who cannot join
- Indeterminate diagnosis, pregnant, breastfeeding, or other contraindication to PET-CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Role of PET-CT for Diagnosis and Assessment of Therapeutic Efficacy in Inflammatory Bowel Disease
The main hypothesis is that PET-CT will be a valuable diagnostic tool in diagnosing and evaluating treatment for IBD.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- PET-CT
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Does this technique provide an accurate assessment of disease inflammation compared to standard clinical markers?
Secondary outcomes (1)
Does this technique provide additional information for practitioners on extent of disease?
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: No Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall Meisner, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205062
- Sponsor's protocol ID
- M-2004-0251
- Status last verified
- Sep 2008
- First submitted
- 13 Sep 2005
- Last updated
- 5 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Role of PET-CT for Diagnosis and Assessment of Therapeutic Efficacy in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00205062
- Acronym / sponsor ID
- M-2004-0251
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No Accrual
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Sep 2005 (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 main hypothesis is that PET-CT will be a valuable diagnostic tool in diagnosing and evaluating treatment for IBD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (1 listed)
- Patient with either Crohn's disease or ulcerative colitis whose disease is flaring
Key exclusion criteria (1 listed)
- Indeterminate diagnosis, pregnant, breastfeeding, or other contraindication to PET-CT
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 | Procedure or surgery | – |
Primary outcome
Does this technique provide an accurate assessment of disease inflammation compared to standard clinical markers?
1 secondary outcome
Does this technique provide additional information for practitioners on extent of disease?
Results and safety
The study was stopped early (reason given: No Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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.
Randall Meisner, MD principal investigator
University of Wisconsin, Madison
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 PET-CT in people with Inflammatory Bowel Diseases, run by University of Wisconsin, Madison 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 1 inclusion and 1 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 5 Oct 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.
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?
The study was stopped early (reason given: No Accrual). 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?
Does this technique provide an accurate assessment of disease inflammation compared to standard clinical markers?. 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 5 Oct 2015.