Colon CancerCOLOPET1NCT01636674
18F-FDG PET/CT and Molecular Tumor Characterisation for Staging and Follow-up of Colon Cancer
A study testing 18F-fluordeoxyglucose positron emission tomography/ computed tomography in people with Colon Cancer, run by Naestved Hospital.
Trial summary
The investigators are investigating the usefulness of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography (18F-FDG PET/CT) for staging and follow-up of colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- 18F-fluordeoxyglucose positron emission tomography/ computed tomography
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Mar 2013
- Phase
- Interventional
- 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
- clinical or histological diagnosis of malignant clonic neoplasm (distance of more than 15 cm from anal ring)
- 18 years of age or older
- written informed consent
Who cannot join
- diabetes
- known malignant disease other than colon cancer
- known metastatic disease
- impairment of renal function
- allergy to CT contrast agents
- body weight of more than 150 kg
- claustrophobia
About this study
Official title: Value of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography and Molecular Tumor Characterisation in Preoperative Staging og Postoperative Control of Colon Cancer
The investigators are investigating the usefulness of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography (18F-FDG PET/CT) for staging and follow-up of colon cancer. Furthermore, the investigators combine 18F-FDG PET findings with clinical and histopathological features, circulating tumor cell (CTC) analyses, tumor gene expression and measurements of circulating cancer biomarkers sUPAR, TIMP-1 and CEA in order to predict tumor recurrence.
The investigators hypothesis: The combination of functional imaging by 18F-FDG PET/CT and pre-existing and evolving molecular biomarkers will optimize tumor characterization, staging of disease and early detection of recurrence.
- Conditions
- Colon Cancer
- Being tested
- 18F-fluordeoxyglucose positron emission tomography/ computed tomography
- Keywords
- positron emission tomography, computed tomography, fluordeoxyglucose, colon cancer, cancer, staging, imaging
- Medical subject headings
- Colonic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluordeoxyglucose positron emission tomography/ computed tomographyOther
18F-fluordeoxyglucose positron emission tomography/ computed tomography for preoperative staging and post-operative follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
time to recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJul 2009
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen University Hospital, Rigshospitalet, Region Zealand
- Responsible party
- Principal investigator, Bodil Elisabeth Engelmann, Naestved Hospital
- Investigators
- Bodil E Engelmann, MD, Principal investigator, Naestved Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636674
- Sponsor's protocol ID
- SJ-82
- Acronym
- COLOPET1
- Status last verified
- Jul 2012
- First submitted
- 6 Jul 2012
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography and Molecular Tumor Characterisation in Preoperative Staging og Postoperative Control of Colon Cancer
- ClinicalTrials.gov ID
- NCT01636674
- Acronym / sponsor ID
- COLOPET1 / SJ-82
- Conditions
- Colon Cancer
- Keywords
- positron emission tomography, computed tomography, fluordeoxyglucose, colon cancer, cancer, staging, imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen University Hospital, Rigshospitalet, Region Zealand
- Study start
- Jul 2009
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 10 Jul 2012 (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 investigators are investigating the usefulness of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography (18F-FDG PET/CT) for staging and follow-up of colon cancer. Furthermore, the investigators combine 18F-FDG PET findings with clinical and histopathological features, circulating tumor cell (CTC) analyses, tumor gene expression and measurements of circulating cancer biomarkers sUPAR, TIMP-1 and CEA in order to predict tumor recurrence.
The investigators hypothesis: The combination of functional imaging by 18F-FDG PET/CT and pre-existing and evolving molecular biomarkers will optimize tumor characterization, staging of disease and early detection of recurrence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- 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 (3 listed)
- clinical or histological diagnosis of malignant clonic neoplasm (distance of more than 15 cm from anal ring)
- 18 years of age or older
- written informed consent
Key exclusion criteria (7 listed)
- diabetes
- known malignant disease other than colon cancer
- known metastatic disease
- impairment of renal function
- allergy to CT contrast agents
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 |
|---|---|---|
| 18F-fluordeoxyglucose positron emission tomography/ computed tomography18F-fluordeoxyglucose positron emission tomography/ computed tomography for preoperative staging and post-operative follow-up | Other | – |
Primary outcome
time to recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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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.
Bodil E Engelmann, MD principal investigator
Naestved Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 18F-fluordeoxyglucose positron emission tomography/ computed tomography in people with Colon Cancer, run by Naestved Hospital.
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 7 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 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
time to recurrence. 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 Jul 2012.