Liver Perfusion MRI With Quantification of Tumoral Perfusion for Early Assessment of the Response of Antiangiogenics Treatments in Hepatocellular Carcinoma (ETAFIRM)
Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide with an incidence of 500 000 cases per year. HCC most commonly appears in a context of liver chronic disease (patient with chronic viral hepatitis (hepatitis B or hepatitis C) or with cirrhosis). Surgical resection and liver transplantation concern patients with early stage and are the only curative treatments. Transcatheter arterial chemoembolization, Radiation Therapy and antiangiogenics treatments concern patients with inoperable lesions (palliative treatments).
Antiangiogenic treatments enable to inhibit the angiogenesis process and thus interrupt the blood supply to the tumor. In clinical practice, the efficacy of anti-angiogenic agents is usually assessed by methods based on morphological medical imaging. The measures of each target lesion are obtained by Response Evaluation Criteria In Solid Tumor (RECIST) criteria and WHO.
However, these morphological measures are not fully evaluated. An alternative to these is the functional medical imaging which assess changes before that a diminution of tumor size is detectable. Since these treatments induce generally necrosis without modification of initial tumor size, the new technologies of functional medical imaging are particularly adapted to an early evaluation of the response to treatments which may improve patient management.
In this context, liver Perfusion MRI needs to be assessed in its capacities to early predict the response of antiangiogenic treatments.
Positive results will enable to adapt therapy in order to improve overall survival of patients and avoid expensive treatments which may turn out to be inefficient and generating important side-effects.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
|Official Title:||Liver Perfusion MRI With Quantification of Tumoral Perfusion for Early Assessment of the Response of Antiangiogenics Treatments in Hepatocellular Carcinoma|
- Response to angiogenic treatment following morphological RECIST criteria [ Time Frame: 7 days after angiogenic treatment ]
- Survival without tumor progression [ Time Frame: 7 days after angiogenic treatment ]
- Global survival [ Time Frame: 7 days after angiogenic treatment ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
Experimental: liver Perfusion MRI
liver perfusion MRI will be performed in patients to assess the early response (7 days) to antiangiogenic treatments
|Device: liver Perfusion MRI|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02585687
|Contact: Agnès RODE, MD, PhD||+33 4 72 07 18 email@example.com|
|Service d'Imagerie, MédicaleHôpital Croix-Rousse||Recruiting|
|Lyon, France, 69004|
|Contact: Agnès RODE, MD, PhD +33 4 72 07 18 83 firstname.lastname@example.org|
|Principal Investigator: Agnès RODE, MD, PhD|
|Principal Investigator:||Agnès RODE, MD, PhD||Service d'Imagerie Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon|