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18F-FDG PET/CT and Molecular Tumor Characterisation for Staging and Follow-up of Colon Cancer (COLOPET1)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Bodil Elisabeth Engelmann, Naestved Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636674
First Posted: July 10, 2012
Last Update Posted: July 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Copenhagen
Rigshospitalet, Denmark
Region Zealand
Information provided by (Responsible Party):
Bodil Elisabeth Engelmann, Naestved Hospital
  Purpose

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.


Condition Intervention
Colon Cancer Other: 18F-fluordeoxyglucose positron emission tomography/ computed tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Value of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography and Molecular Tumor Characterisation in Preoperative Staging og Postoperative Control of Colon Cancer

Resource links provided by NLM:


Further study details as provided by Bodil Elisabeth Engelmann, Naestved Hospital:

Primary Outcome Measures:
  • time to recurrence

Enrollment: 66
Study Start Date: July 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 18F-fluordeoxyglucose positron emission tomography/ computed tomography
    18F-fluordeoxyglucose positron emission tomography/ computed tomography for preoperative staging and post-operative follow-up
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636674


Sponsors and Collaborators
Naestved Hospital
University of Copenhagen
Rigshospitalet, Denmark
Region Zealand
Investigators
Principal Investigator: Bodil E Engelmann, MD Naestved Hospital
  More Information

Responsible Party: Bodil Elisabeth Engelmann, MD, research fellow, Naestved Hospital
ClinicalTrials.gov Identifier: NCT01636674     History of Changes
Other Study ID Numbers: SJ-82
First Submitted: July 6, 2012
First Posted: July 10, 2012
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Bodil Elisabeth Engelmann, Naestved Hospital:
positron emission tomography
computed tomography
fluordeoxyglucose
colon cancer
cancer
staging
imaging

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases