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

Naestved Hospital

Status: Unknown

Conditions: Colon Cancer

Treatments: Other: 18F-fluordeoxyglucose positron emission tomography/ computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT01636674

SJ-82

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)