Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145665
Status:
TERMINATED
Last Update Posted:
2011-09-05
First Post:
2005-09-01
Brief Title:
The Role of Fluorothymidine Positron Emission Tomography FLT-PET in Proliferation of Colorectal Liver Metastases
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
The Role of 3-Deoxy-318Fluorothymidine Positron Emission Tomography FLT-PET in Proliferation of Colorectal Liver Metastases
Status:
TERMINATED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no accrual achieved
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 n40 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 n80
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 085 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 005 one-sided beta 090 assuming that an acceptable difference in sensitivity between both tests is 0 and an unacceptable difference is 002 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
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 n40 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 n80
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 085 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 005 one-sided beta 090 assuming that an acceptable difference in sensitivity between both tests is 0 and an unacceptable difference is 002 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None