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The Role of FLT-PET in Proliferation of Colorectal Livermetastases - Article


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Clinical Trial: The Role of FLT-PET in Proliferation of Colorectal Livermetastases

This study is currently recruiting patients.
Verified by Radboud University September 2005

Sponsored by: Radboud University
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00145665

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 livermetastases, so that the risc of recurrence can be identified in a noninvasive way, concerning patients with resectable colorectal livermetastases.

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

Condition Intervention Phase
Colorectal Neoplasms
Liver Neoplasms
Recurrence
 Procedure: FLT-PET scan
Phase I
Phase II

MedlinePlus related topics:  Colorectal Cancer;   Liver Cancer

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study

Official Title: The Role of 3-Deoxy-3[18]Fluorthymidin Positron Emission Tomography (FLT-PET) in Proliferation of Colorectal Livermetatsases

Further Study Details: 
Primary Outcomes: correlation FLT-uptake in colorectal livermetastases and the histological determined proliferation
Secondary Outcomes: correlation FLT and recurrence rate
Expected Total Enrollment:  80

Study start: January 2005;  Expected completion: December 2009
Last follow-up: July 2005;  Data entry closure: December 2007

Aim of the study:

Validation of FLT-PET as a proliferationmarker for colorectal livermeastases, so that the risc of recurrence in patients with resected colorectal livermetastases can be assessed in a noninvasive method.

Studydesign:

Validationstudy (n=40) to determine the correlation between kwantitative FLT-PET (in this study determined before resection of the colorectal livermetastases) and the hitological detrmined proliferation index in the resected specimen of the metastases (''''golden standard''''). If correlation is established, the correlation between the proliferation and recurence rate is studied also (n=80).

Studypopulation:

Patients with colorectal livermetastases.

Intervention:

FLT-PET sscan

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 resction of the livermetasases. Recently several papers describe dat the proliferation index of the livermetastasis 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 essentail role and contribute to beter selection of patients suitable for resection.

Diagnostics on proliferation:

Seeing that the proliferation rate is preoperatively not determined without a biopsie (which is contraindicated due to dissemination), all patients with colorectal livermetastases (with no signs of extrahepatic deposits) are resected, without knowledge of the proliferation. FLT is a marker that visualizes prolifaration and thus seems an ideal candidate to determin the proliferation rate in a noninvase method. As of yet no validationstudies of FLT-PET in colorectal livermetastases have been described.

Evaluation:

Quantative 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 inlcusion of patienst will be extended from 40 to 80 patients, seeing that this will give us teh 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 suty will be proposed with the introduction of neoadjuvant chemotherapy, where the selection will determined on basis of the proliferation rate.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • pregnancy
  • recent chemotherapy

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00145665

Wim JM Oyen, MD, PhD      +31-24-3614048    w.oyen@nucmed.umcn.nl
Bastiaan Wiering, MD      +31-24-3617365    b.wiering@chir.umcn.nl

Netherlands, Gelderland
      Radboud University, Nijmegen,  Gelderland,  6500 HB,  Netherlands; Recruiting
B Wiering
W Oyen
B Wiering,  Principal Investigator
W Oyen,  Principal Investigator
T Ruers,  Principal Investigator

Study chairs or principal investigators

Bastiaan Wiering, MD,  Principal Investigator,  Radboud University   
Theo MJ Ruers, MD, PhD,  Principal Investigator,  Radboud University   
Wim JG Oyen, MD, PhD,  Principal Investigator,  Radboud University   

More Information

Publications

Fong Y, Cohen AM, Fortner JG, Enker WE, Turnbull AD, Coit DG, Marrero AM, Prasad M, Blumgart LH, Brennan MF. Liver resection for colorectal metastases. J Clin Oncol. 1997 Mar;15(3):938-46.

Hughes KS, Rosenstein RB, Songhorabodi S, Adson MA, Ilstrup DM, Fortner JG, Maclean BJ, Foster JH, Daly JM, Fitzherbert D, et al. Resection of the liver for colorectal carcinoma metastases. A multi-institutional study of long-term survivors. Dis Colon Rectum. 1988 Jan;31(1):1-4.

Gibbs JF, Weber TK, Rodriguez-Bigas MA, Driscoll DL, Petrelli NJ. Intraoperative determinants of unresectability for patients with colorectal hepatic metastases. Cancer. 1998 Apr 1;82(7):1244-9.

Tullo A, D''''Erchia AM, Honda K, Mitry RR, Kelly MD, Habib NA, Saccone C, Sbisa E. Characterization of p53 mutations in colorectal liver metastases and correlation with clinical parameters. Clin Cancer Res. 1999 Nov;5(11):3523-8.

Buck AK, Schirrmeister H, Hetzel M, Von Der Heide M, Halter G, Glatting G, Mattfeldt T, Liewald F, Reske SN, Neumaier B. 3-deoxy-3-[(18)F]fluorothymidine-positron emission tomography for noninvasive assessment of proliferation in pulmonary nodules. Cancer Res. 2002 Jun 15;62(12):3331-4.

Buck AK, Halter G, Schirrmeister H, Kotzerke J, Wurziger I, Glatting G, Mattfeldt T, Neumaier B, Reske SN, Hetzel M. Imaging proliferation in lung tumors with PET: 18F-FLT versus 18F-FDG. J Nucl Med. 2003 Sep;44(9):1426-31.

Francis DL, Visvikis D, Costa DC, Arulampalam TH, Townsend C, Luthra SK, Taylor I, Ell PJ. Potential impact of [18F]3''''-deoxy-3''''-fluorothymidine versus [18F]fluoro-2-deoxy-D-glucose in positron emission tomography for colorectal cancer. Eur J Nucl Med Mol Imaging. 2003 Jul;30(7):988-94. Epub 2003 May 9.

Vesselle H, Grierson J, Peterson LM, Muzi M, Mankoff DA, Krohn KA. 18F-Fluorothymidine radiation dosimetry in human PET imaging studies. J Nucl Med. 2003 Sep;44(9):1482-8.

Rodgers MS, Collinson R, Desai S, Stubbs RS, McCall JL. Risk of dissemination with biopsy of colorectal liver metastases. Dis Colon Rectum. 2003 Apr;46(4):454-8; discussion 458-9.

Study ID Numbers:  FLT-PET CRC-LM
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145665
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-06

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Page Updated: September 6, 2005
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