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

NCT ID: NCT01636674

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer

Keywords

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positron emission tomography computed tomography fluordeoxyglucose colon cancer cancer staging imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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18F-fluordeoxyglucose positron emission tomography/ computed tomography

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Region Zealand

OTHER

Sponsor Role collaborator

Naestved Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bodil Elisabeth Engelmann

MD, research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bodil E Engelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Naestved Hospital

Other Identifiers

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SJ-82

Identifier Type: -

Identifier Source: org_study_id