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Brief Title: Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases
Official Title: Medical and Economical Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases
Study ID: NCT00489697
Brief Summary: Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies. The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy in patient with metastatic colorectal cancer. The primary objective of this study is to compare the functional vascular changes related to bevacizumab based chemotherapy and evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the bevacizumab.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHRU d'ANGERS, Angers, , France
CRLCC, Centre Paul Papin, Angers, , France
CHRU Besancon, Besançon, , France
Hôpital Saint-André, CHRU Bordeaux, Bordeaux, , France
CRLCC, Centre René Gauducheau, Nantes St Herblain, , France
Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris, Paris, , France
Hôpital Haut-Lévêque, Pessac, , France
Hôpital La Milétrie, CHRU Poitiers, Poitiers, , France
Hôpital Robert Debré, CHRU Reims, Reims, , France
CHU Pontchaillou, Rennes, , France
CRLCC, Centre Eugène Marquis, Rennes, , France
Chru Tours, Tours, , France
Name: François TRANQUART, Professor
Affiliation: Centre Hospitalier de Tours, France
Role: PRINCIPAL_INVESTIGATOR
Name: Thierry LECOMTE, Doctor
Affiliation: Centre Hospitalier de Tours, France
Role: PRINCIPAL_INVESTIGATOR
Name: Bruno GIRAUDEAU, Doctor
Affiliation: INSERM CIC 2002, Centre Hospitalier de Tours, France
Role: STUDY_CHAIR
Name: Emmanuel RUSCH, Professor
Affiliation: Centre Hospitalier de Tours, France
Role: STUDY_CHAIR