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Clinical Trials/NCT01636674
NCT01636674UnknownNot Applicable

Value of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography and Molecular Tumor Characterisation in Preoperative Staging og Postoperative Control of Colon Cancer

Naestved Hospital0 sites66 target enrollmentStarted: July 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
66
Primary Endpoint
time to recurrence

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • 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

Outcomes

Primary Outcomes

time to recurrence

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bodil Elisabeth Engelmann

MD, research fellow

Naestved Hospital

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