Actualisation et mise en ligne de nouvelles bonnes pratiques de soins infirmiers : découvrez-les sans plus tarder
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Titre abrégé
PROACTIF (BTG-007996-01)
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NCT
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N° Eudract
2018-A02412-53
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Phase de l'essai
- Phase III
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Type de promoteur
Académique / Institutionnel
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Nom du promoteur
BTG Biocompatible UK Ltd
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- All patients for whom treatment with TheraSphere® has been prescribed and reimbursed in France will be eligible for this study. It is estimated that data from >500 patients will be entered into this registry from approximately 30 sites in France. - non
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CONTRAINDICATION FOR THERASPHERE® TREATMENT 1. Patient with measured tumour volume >50% 2. Patients with PV(T)T type IV with complete main portal vein invasion closed to the portal bifurcation and with a poor 99mTc-MAA targeting. Note: Patients with incomplete invasion and good 99mTc-MAA targeting can be considered. 3. Bilirubin >2 mg/dL or >34 ¼mol/L 4. AST/ALT >5 x ULN 5. Ascites > grade 1 under well conducted diuretic treatment (Appendix 7) 6. Child Pugh score > B7 7. Patient with hepatic reserve d"30% of total liver volume and dose to the perfused non-tumoural liver e" 120G (determined with 99mTc-MAA SPECT/SPECT/CT). 8. Any other contraindication listed in the TheraSphere® Instructions for Use (IFU). 9. Patients with infiltrative disease.
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Nom du centre
HCL - Hôpital Edouard Herriot
Lyon -
Contact Investigateur
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Nom
Frederique GAY
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Contact ARC/TER/IRC
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Nom
Sabine DEBEER
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Nom du centre
HCL - Hôpital de la Croix-Rousse
Lyon -
Contact Investigateur
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Nom
Agnes RODE
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Contact ARC/TER/IRC
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Nom
Hayette DJOUADI