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

NCT00145665 | Terminated Phase 1

• 1 other identifier: FLT-PET CRC-LM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms; Liver Neoplasms

Keywords

FLT-PET; colorectal liver metastases; proliferation; proliferation markers; recurrence

Outcome Measures

Primary Outcomes (1)

• correlation FLT-uptake in colorectal liver metastases and the histologically determined proliferation

Secondary Outcomes (1)

• correlation FLT and recurrence rate

Interventions

FLT-PET scan PROCEDURE

PET scan using FLT

Also known as: [18F]-3'-fluoro-3'-deoxy-L-thymidine Positron emission tomography scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Recent chemotherapy

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (9)

• 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. doi: 10.1200/JCO.1997.15.3.938.

  PMID: 9060531 BACKGROUND

• 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. doi: 10.1007/BF02552560.

  PMID: 3366020 BACKGROUND

• 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. doi: 10.1002/(sici)1097-0142(19980401)82:73.0.co;2-f.

  PMID: 9529015 BACKGROUND

• 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.

  PMID: 10589767 BACKGROUND

• 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.

  PMID: 12067968 BACKGROUND

• 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.

  PMID: 12960187 BACKGROUND

• 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. doi: 10.1007/s00259-003-1187-0. Epub 2003 May 9.

  PMID: 12739071 BACKGROUND

• 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.

  PMID: 12960196 BACKGROUND

• 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. doi: 10.1007/s10350-004-6581-6.

  PMID: 12682536 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Liver Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bastiaan Wiering, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Theo MJ Ruers, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Wim JG Oyen, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: September 5, 2011

Record last verified: 2007-02

Locations

NL (1)