18F-FDG PET/CT and Molecular Tumor Characterisation for Staging and Follow-up of Colon Cancer (COLOPET1)
Primary Purpose
Colon Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
18F-fluordeoxyglucose positron emission tomography/ computed tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Cancer focused on measuring positron emission tomography, computed tomography, fluordeoxyglucose, colon cancer, cancer, staging, imaging
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
time to recurrence
Secondary Outcome Measures
Full Information
NCT ID
NCT01636674
First Posted
July 6, 2012
Last Updated
July 9, 2012
Sponsor
Naestved Hospital
Collaborators
University of Copenhagen, Rigshospitalet, Denmark, Region Zealand
1. Study Identification
Unique Protocol Identification Number
NCT01636674
Brief Title
18F-FDG PET/CT and Molecular Tumor Characterisation for Staging and Follow-up of Colon Cancer
Acronym
COLOPET1
Official Title
Value of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography and Molecular Tumor Characterisation in Preoperative Staging og Postoperative Control of Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Naestved Hospital
Collaborators
University of Copenhagen, Rigshospitalet, Denmark, Region Zealand
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
positron emission tomography, computed tomography, fluordeoxyglucose, colon cancer, cancer, staging, imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
18F-fluordeoxyglucose positron emission tomography/ computed tomography
Intervention Description
18F-fluordeoxyglucose positron emission tomography/ computed tomography for preoperative staging and post-operative follow-up
Primary Outcome Measure Information:
Title
time to recurrence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bodil E Engelmann, MD
Organizational Affiliation
Naestved Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
18F-FDG PET/CT and Molecular Tumor Characterisation for Staging and Follow-up of Colon Cancer
We'll reach out to this number within 24 hrs