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

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
18F-fluordeoxyglucose positron emission tomography/ computed tomography
Sponsored by
Naestved Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring positron emission tomography, computed tomography, fluordeoxyglucose, colon cancer, cancer, staging, imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    time to recurrence

    Secondary Outcome Measures

    Full Information

    First Posted
    July 6, 2012
    Last Updated
    July 9, 2012
    Sponsor
    Naestved Hospital
    Collaborators
    University of Copenhagen, Rigshospitalet, Denmark, Region Zealand
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01636674
    Brief Title
    18F-FDG PET/CT and Molecular Tumor Characterisation for Staging and Follow-up of Colon Cancer
    Acronym
    COLOPET1
    Official Title
    Value of 18F-Fluordeoxyglucose Positron Emission Tomography/ Computed Tomography and Molecular Tumor Characterisation in Preoperative Staging og Postoperative Control of Colon Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    March 2013 (Anticipated)
    Study Completion Date
    March 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Naestved Hospital
    Collaborators
    University of Copenhagen, Rigshospitalet, Denmark, Region Zealand

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Cancer
    Keywords
    positron emission tomography, computed tomography, fluordeoxyglucose, colon cancer, cancer, staging, imaging

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    18F-fluordeoxyglucose positron emission tomography/ computed tomography
    Intervention Description
    18F-fluordeoxyglucose positron emission tomography/ computed tomography for preoperative staging and post-operative follow-up
    Primary Outcome Measure Information:
    Title
    time to recurrence

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bodil E Engelmann, MD
    Organizational Affiliation
    Naestved Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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