Back to resultsEvaluation of Metabolic Activity of Liver Metastases by FDG-PET Scanning
Primary Purpose
Colorectal Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
FDG-PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Neoplasms focused on measuring colorectal cancer, liver metastases, metabolic activity
Eligibility Criteria
Inclusion Criteria: Colorectal cancer and synchronous liver metastases Exclusion Criteria: Pregnancy
Sites / Locations
- Radboud University Nijmegen Medical CentreRecruiting
Outcomes
Primary Outcome Measures
Increase in metabolic activity of liver metastases after resection of the primary tumor compared to the activity of metastases in patients without primary tumor resection
Secondary Outcome Measures
Full Information
NCT ID
NCT00184782
First Posted
September 12, 2005
Last Updated
September 20, 2007
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00184782
Brief Title
Evaluation of Metabolic Activity of Liver Metastases by FDG-PET Scanning
Official Title
Exploratory Study on FDG-PET Scanning in Evaluating the Metabolic Activity of Liver Metastases Before and After Resection of the Primary Tumor in Patients With a Colorectal Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of primary tumor resection on the metabolic activity of metastases in patients with a colorectal primary tumor and synchronous liver metastases by positron emission tomography (PET) with 2-deoxy-2-fluoro[18F]-D-glucose (FDG-PET) scanning.
Detailed Description
The goal of this study is to evaluate the activity of liver metastases before and after resection of the primary tumor. Non-invasive assessment of tumor metabolism is possible in vivo by means of positron emission tomography (PET)-scanning. Therefore, FDG-PET scan offers a suitable approach to determine the influence of removal of a primary colorectal tumor on metabolic activity of the liver metastases. The FDG uptake in the liver metastases is quantified by calculating standardised uptake values (SUVs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
colorectal cancer, liver metastases, metabolic activity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
FDG-PET
Primary Outcome Measure Information:
Title
Increase in metabolic activity of liver metastases after resection of the primary tumor compared to the activity of metastases in patients without primary tumor resection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colorectal cancer and synchronous liver metastases
Exclusion Criteria:
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Peeters, MD
Phone
+31-24-3611111
Ext
17365
Email
C.Peeters@chir.umcn.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Theo Ruers, PhD
Phone
+31-24-3611111
Ext
17365
Email
T.Ruers@chir.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theo Ruers, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Peeters, MD
Phone
+31-24-3611111
Ext
17365
Email
C.Peeters@chir.umcn.nl
First Name & Middle Initial & Last Name & Degree
Theo Ruers, PhD
Phone
+31-24-3611111
Ext
17365
Email
T.Ruers@chir.umcn.nl
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Metabolic Activity of Liver Metastases by FDG-PET Scanning
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