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Spots Global Cancer Trial Database for Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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