A Prospective, Post Approval, Multiple Centre, Open-Label, NonInterventional, Registry Study to Evaluate Effectiveness of TheraSphere® in Clinical Practice in France
Ouvert
Mis à jour le 10/01/2024
Cancers digestifs (foie)
Informations générales
  • Titre abrégé

    PROACTIF (BTG-007996-01)

  • NCT

    NCT04069468

  • N° Eudract

    2018-A02412-53

  • Phase de l'essai
    • Phase III
Promoteur
  • Type de promoteur

    Académique / Institutionnel

  • Nom du promoteur

    BTG Biocompatible UK Ltd

Critères d'inclusion
  • - 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
Critères d'exclusion
  • 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.
Centre investigateur 1
  • Nom du centre

    HCL - Hôpital Edouard Herriot
    Lyon

  • Contact Investigateur

  • Nom

    Pierre-Jean VALETTE

  • Contact ARC/TER/IRC

  • Nom

    Sabine DEBEER

  • Email

    sabine.debeer@chu-lyon.fr

Centre investigateur 2
  • Nom du centre

    HCL - Hôpital de la Croix-Rousse
    Lyon

  • Contact Investigateur

  • Nom

    Agnes RODE

  • Contact ARC/TER/IRC

  • Nom

    Hayette DJOUADI

  • Email

    hayette.djouadi@chu-lyon.fr

Centre investigateur 3
  • Nom du centre

    Centre Léon Bérard
    Lyon

  • Contact Investigateur

  • Nom

    Dr. Franck GRILLET

  • Autre contact

    Dr GUIBERT Pierre ; Dr PARISSE-DI MARTINO Sandrine ; Pr PILLEUL Frank ;

  • Contact ARC/TER/IRC

  • Nom

    Mme Justine ARVERS

Centre investigateur 4
  • Nom du centre

    CHU Grenoble Alpes - Hôpital Nord

  • Contact Investigateur

  • Nom

    SENGEL Christian

  • Contact ARC/TER/IRC

  • Nom

    imagerie ARC