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Sponsored by: |
Universitaire Ziekenhuizen Leuven |
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Information provided by: | Universitaire Ziekenhuizen Leuven |
ClinicalTrials.gov Identifier: | NCT00828620 |
Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.
Condition | Intervention |
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Metastatic Colorectal Cancer |
Other: Imaging study |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Imaging for Early Response Prediction to EGF-Receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer |
Estimated Enrollment: | 80 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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PET-CT
Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab
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Other: Imaging study
PET-CT
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
unresectable stage IV colorectal cancer pathologically proven measurable disease (RECIST) K-RAS wild type Eligible for 3rd line Irinotecan + Cetuximab Able for tolerate PET/CT imaging Serum glucose < 200mg/dl
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
UZLeuven | |
Leuven, Belgium, 3000 | |
ZNA Middelheim | |
Antwerpen, Belgium | |
Sint Augustinus Ziekenhuis | |
Wilrijk, Belgium |
Principal Investigator: | Eric Van Cutsem, Prof.Dr | UZ Leuven |
Responsible Party: | UZ Leuven ( Prof. Dr. Eric Van Cutsem ) |
Study ID Numbers: | s51276 - ML5241 |
Study First Received: | January 23, 2009 |
Last Updated: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00828620 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Cetuximab Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Antibodies, Monoclonal Antibodies Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms Immunoglobulins |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |