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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01636674
Other study ID # SJ-82
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 6, 2012
Last updated July 9, 2012
Start date July 2009
Est. completion date March 2013

Study information

Verified date July 2012
Source Naestved Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Ministry of Health
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 66
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
18F-fluordeoxyglucose positron emission tomography/ computed tomography
18F-fluordeoxyglucose positron emission tomography/ computed tomography for preoperative staging and post-operative follow-up

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Naestved Hospital Region Zealand, Rigshospitalet, Denmark, University of Copenhagen

Outcome

Type Measure Description Time frame Safety issue
Primary time to recurrence
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