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- Klinische proef NCT02585687
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Lyon, Frankrijk, 69004
- Service d'Imagerie, MédicaleHôpital Croix-Rousse
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients with hepatocellular carcinoma diagnosis according to Barcelona Clinic Liver Cancer (BCLC) staging and European Association for Study of Liver (EASL) criteria or histologically confirmed diagnosis (biopsy).
- Patients with untreated hepatocellular carcinoma, not suitable for curative treatment and having an anti-angiogenic treatment.
- Patients with no contra-indication to sorafenib treatment
- The previous treatment with surgery, chemo-embolization, radiofrequency, or conformal radiotherapy are not contra-indications to the inclusion
- Patients agreeing to participate (signed inform consent)
Exclusion Criteria:
- Patients with contra-indication to sorafenib treatment
- MRI contra-indication: ferromagnetic material, pacemaker, intraocular foreign bodies, claustrophobia, creatinine clearance below 30 ml / min by Modification of Diet in Renal Disease (MDRD) method
- True allergy to gadobenate dimeglumine
- Patients suffering from acute renal failure or chronic severe (GFR <30 ml/min/1, 73 m²) and patients suffering from acute renal failure (regardless of severity) due to an hepatorenal syndrome
- Pregnancy or breast-feeding
- Refusal to sign the informed consent
- Patient has already been included in another study that could interfere with the results of the study. - Patients not affiliated to either the French social security system or an European health insurance.
- All persons deprived of liberty by a judicial or administrative law, patients hospitalized without consent under Articles L. 3212-1 and L. 3213-1 which are not covered by the provisions of Article L. 1121-8
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Screening
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: liver Perfusion MRI
liver perfusion MRI will be performed in patients to assess the early response (7 days) to antiangiogenic treatments
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Response to angiogenic treatment following morphological RECIST criteria
Tijdsspanne: 7 days after angiogenic treatment
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7 days after angiogenic treatment
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Survival without tumor progression
Tijdsspanne: 7 days after angiogenic treatment
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7 days after angiogenic treatment
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Global survival
Tijdsspanne: 7 days after angiogenic treatment
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7 days after angiogenic treatment
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Agnès RODE, MD, PhD, Service d'Imagerie Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2011.693
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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University of Alabama at BirminghamWervingAlvleesklierkankerVerenigde Staten
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Qilu Hospital of Shandong UniversityNog niet aan het wervenAcuut nierletsel | Aneurysma, ontleden
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Northwestern UniversityWervingKwetsbaarheid | Cirrose | LevertransplantatieVerenigde Staten
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Washington University School of MedicineOrganOx Ltd.; Mid-America TransplantWervingLever Ziekten | Chirurgie | Transplantatie; Falen, leverVerenigde Staten
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Assistance Publique Hopitaux De MarseilleActief, niet wervend
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Cambridge University Hospitals NHS Foundation TrustWervingBorstkankerVerenigd Koninkrijk
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Chelsea and Westminster NHS Foundation TrustImperial College Healthcare NHS Trust; University of WestminsterVoltooidErnstige verwondingVerenigd Koninkrijk