The Role of Fluorothymidine Positron Emission Tomography (FLT-PET) in Proliferation of Colorectal Liver Metastases

This study has been terminated.
(no accrual achieved)
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00145665
First received: September 1, 2005
Last updated: September 2, 2011
Last verified: February 2007
  Purpose

The aim of the study is to obtain information on FLT used in a PET-scan as a marker for the proliferation of colorectal liver metastases, so that the risk of recurrence can be identified in a noninvasive way, concerning patients with resectable colorectal liver metastases.

The hypothesis of this study is that a higher uptake of FLT in the liver metastases has a good correlation with the proliferation rate of the metastases. This rate is related to the risk of recurrence.


Condition Intervention Phase
Colorectal Neoplasms
Liver Neoplasms
Procedure: FLT-PET scan
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Role of 3-Deoxy-3[18]Fluorothymidine Positron Emission Tomography (FLT-PET) in Proliferation of Colorectal Liver Metastases

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • correlation FLT-uptake in colorectal liver metastases and the histologically determined proliferation

Secondary Outcome Measures:
  • correlation FLT and recurrence rate

Estimated Enrollment: 80
Study Start Date: January 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: FLT-PET scan
    PET scan using FLT
    Other Name: [18F]-3'-fluoro-3'-deoxy-L-thymidine Positron emission tomography scan
Detailed Description:

Aim of the Study:

Validation of FLT-PET as a proliferation marker for colorectal liver metastases, so that the risk of recurrence in patients with resected colorectal liver metastases can be assessed in a noninvasive method.

Study Design:

Validation study (n=40) to determine the correlation between quantitative FLT-PET (in this study determined before resection of the colorectal liver metastases) and the histologically determined proliferation index in the resected specimen of the metastases ('golden standard'). If correlation is established, the correlation between the proliferation and recurrence rate studied is also (n=80).

Study Population:

Patients with colorectal liver metastases.

Intervention:

FLT-PET scan

Scientific Basis of Study:

Several reports show that presence or absence of extrahepatic disease is a determining prognostic factor. Patients with extrahepatic disease are rarely suited for resection of the liver metastases. Recently several papers describe that the proliferation index of the liver metastases is another determining prognostic factor. Patients with a high proliferation factor have a worse prognosis. For both of these determining factors, it seems that PET diagnostics play an essential role and contribute to better selection of patients suitable for resection.

Diagnostics on Proliferation:

Seeing that the proliferation rate is preoperatively not determined without a biopsy (which is contraindicated due to dissemination), all patients with colorectal liver metastases (with no signs of extrahepatic deposits) are resected, without knowledge of the proliferation. FLT is a marker that visualizes proliferation and thus seems an ideal candidate to determine the proliferation rate in a noninvasive method. As of yet no validation studies of FLT-PET in colorectal liver metastases have been described.

Evaluation:

Quantitative histologic data are correlated with the quantitative FLT-PET data. If the correlation is higher that 0.85, this correlation is established. If this correlation is found, the inclusion of patients will be extended from 40 to 80 patients, seeing that this will give us the opportunity to correlate clinical data with the histological data. (alpha = 0.05, one-sided, beta = 0.90, assuming that an acceptable difference in sensitivity between both tests is 0 and an unacceptable difference is 0.02). If this correlation is significant, a new study will be proposed with the introduction of neoadjuvant chemotherapy, where the selection will be determined on basis of the proliferation rate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Colorectal liver metastases deemed resectable on three-phase computed tomography (CT)-scan of the liver
  • No evidence of extrahepatic disease on CT chest and abdomen and possible fluorodeoxyglucose (FDG)-PET (if part of surgical work-up)
  • No evidence of local recurrence or second primary colorectal tumor on colonoscopy or colonography
  • Primary colorectal tumor radically removed
  • Informed consent

Exclusion Criteria:

  • Pregnancy
  • Recent chemotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145665

Locations
Netherlands
Radboud University
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Bastiaan Wiering, MD Radboud University
Principal Investigator: Theo MJ Ruers, MD, PhD Radboud University
Principal Investigator: Wim JG Oyen, MD, PhD Radboud University
  More Information

Publications:

Responsible Party: no sponsor
ClinicalTrials.gov Identifier: NCT00145665     History of Changes
Other Study ID Numbers: FLT-PET CRC-LM
Study First Received: September 1, 2005
Last Updated: September 2, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
FLT-PET
colorectal liver metastases
proliferation
proliferation markers
recurrence

Additional relevant MeSH terms:
Colorectal Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Liver Diseases
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases

ClinicalTrials.gov processed this record on October 21, 2014