Evaluation of Metabolic Activity of Liver Metastases by FDG-PET Scanning

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00184782
• Other study ID #: CP 2005
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 20, 2007
• Start date: September 2003
• Est. completion date: December 2008

Study information

• Verified date: September 2005
• Source: Radboud University
• Contact: Charlotte Peeters, MD
• Phone: +31-24-3611111
• Email: C.Peeters[@]chir.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Colorectal cancer and synchronous liver metastases

Exclusion Criteria:

• Pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Procedure:
• FDG-PET

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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