Colorectal CancerPhase 4NCT00114829
Preoperative Assessment of Colon Tumor
A Phase 4 study testing MR colonography with dynamic contrast uptake in people with Colorectal Cancer and Colorectal Tumor, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Tumor
- What is being tested?
- MR colonography with dynamic contrast uptake
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2005to not given
- 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
- Colorectal cancer
- Colorectal tumor
Who cannot join
- Active diverticulitis
- Pacemaker
- Metal in the body
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Radiology Copenhagen University Hospital Herlev
Herlev, Dk-.2730
Michael P Achiam, M.D, +45 44884391, achiam1@dadlnet.dk
Michael P Achiam, M.D.
About this study
Official title: Preoperative Assessment of Colon Tumor: A Prospective, Blinded Study.
The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.
- Conditions
- Colorectal Cancer, Colorectal Tumor
- Being tested
- MR colonography with dynamic contrast uptake
- Keywords
- Colorectal cancer, Colorectal tumor, Dynamic contrast uptake, MR colonography
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR colonography with dynamic contrast uptakeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity in determining malignant or benign diagnose
Secondary outcomes (1)
Sensitivity/specificity of MR colonography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Investigators
- Michael P Achiam, M.D., Principal investigator, Department of Radiology Copenhagen University Hospital Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114829
- Sponsor's protocol ID
- KA05028-MA
- Other IDs
- KA05028
- Status last verified
- May 2005
- First submitted
- 17 Jun 2005
- Last updated
- 9 Mar 2006
- Results posted
- No
Publications
Achiam MP, Andersen LP, Klein M, Logager V, Chabanova E, Thomsen HS, Rosenberg J. Differentiation between benign and malignant colon tumors using fast dynamic gadolinium-enhanced MR colonography; a feasibility study. Eur J Radiol. 2010 Jun;74(3):e45-50. doi: 10.1016/j.ejrad.2009.03.033. Epub 2009 May 5.
PubMed 19419830
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Assessment of Colon Tumor: A Prospective, Blinded Study.
- ClinicalTrials.gov ID
- NCT00114829
- Acronym / sponsor ID
- KA05028-MA
- Conditions
- Colorectal Cancer, Colorectal Tumor
- Keywords
- Colorectal cancer, Colorectal tumor, Dynamic contrast uptake, MR colonography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Study start
- Jul 2005
- First posted
- 20 Jun 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 purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Colorectal cancer
- Colorectal tumor
Key exclusion criteria (4 listed)
- Active diverticulitis
- Pacemaker
- Metal in the body
- Claustrophobia
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 |
|---|---|---|
| MR colonography with dynamic contrast uptake | Procedure or surgery | – |
Primary outcome
Sensitivity in determining malignant or benign diagnose
1 secondary outcome
Sensitivity/specificity of MR colonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2006.
- Derived from this study: PubMed 19419830Achiam MP, Andersen LP, Klein M, Logager V, Chabanova E, Thomsen HS, Rosenberg J. Differentiation between benign and malignant colon tumors using fast dynamic gadolinium-enhanced MR colonography; a feasibility study. Eur J Radiol. 2010 Jun;74(3):e45-50. doi: 10.1016/j.ejrad.2009.03.033. Epub 2009 May 5.
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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.
Michael P Achiam, M.D. principal investigator
Department of Radiology Copenhagen University Hospital Herlev
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 MR colonography with dynamic contrast uptake in people with Colorectal Cancer and Colorectal Tumor, run by Herlev Hospital at 1 site in Denmark.
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 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 9 Mar 2006. 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 Denmark. 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?
Contact Michael P Achiam, M.D (+45 44884391, achiam1@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity in determining malignant or benign diagnose. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00114829, which also lists 1 linked publication.
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 Mar 2006.