E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hepatocellular carcinoma |
Carcinoma Hepatocelular |
|
E.1.1.1 | Medical condition in easily understood language |
hepatocellular carcinoma |
carcinoma hepatocelular |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049010 |
E.1.2 | Term | Carcinoma hepatocellular |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To establish the diagnostic accuracy of magnetic resonance imaging with gadoxetate disodium for the diagnosis of hepatocellular carcinoma that do not fulfil the established diagnostic criteria as per current guidelines of AASLD (American Association for the Study of Liver Diseases) |
Establecer la precisión diagnóstica de la resonancia magnética realzada con gadoxetato de disodio en fases dinámicas y hepatobiliar en el diagnóstico del carcinoma hepatocelular que no cumple los criterios de diagnóstico no invasivo propuestos por las guías actuales de la AASLD (American Association for the Study of Liver Diseases). |
|
E.2.2 | Secondary objectives of the trial |
1-To define the imaging patterns of hepatocellular carcinoma in cirrhotic patients when studied with gadoxetic acid magnetic resonance imaging including the dynamin phase and the hepatobiliary phase at 10 and 20 minutes after contrast injection 2- To evaluate the usefulness of liver magnetic resonance imaging with gadoxetic acid in the differenciation between bening and malignant nodules in the cirrhotic liver. 3- To determine the diagnosis and clinical significance of the infracentimetric additional nodules detected in the hepatobiliary phase |
1- Definir el patrón de imagen del carcinoma hepatocelular en pacientes cirróticos estudiados mediante resonancia magnética con gadoxetato de disodio incluyendo las fases dinámica y hepatobiliar a los 10 y 20 minutos tras la inyección del contraste. 2- Evaluar la utilidad de la resonancia magnética hepática con gadoxetato de disodio para la diferenciación entre nódulos benignos y malignos en el hígado cirrótico. 3- Determinar el diagnóstico y significado clínico de los nódulos adicionales infracentrimétricos detectados en la fase hepatobiliar. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- more than 18 years old - patient with diagnosis of liver cirrhosis Child Pugh A-B - Patients without previous hepatocellular carcinoma in whom ultrasound detects a suspiciuos hepatic lesion; solitary solid and well-defined nodule between 10 and 20 mm - patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication - patient that agree to parcicipate signing informed consent form |
- Paciente mayor de 18 años. - Paciente con diagnóstico de cirrosis hepática Child Pugh A-B - Paciente sin antecedentes de CHC en el que se ha detectado a través de ecografía un único nódulo sólido y bien definido de tamaño superior a 10 mm y menor o igual a 20 mm - Paciente susceptible de ser tratado tras la detección de un nódulo de CHC - Paciente que otorga su Consentimiento informado por escrito. |
|
E.4 | Principal exclusion criteria |
-Patients with poor liver function who would have undergone transplantation even without hepatocellular carcinoma diagnosis (Child-Pugh C) - patients with previous diagnosis of hepatocellular carcinoma -patients with significant comorbilities that could prevent the optimum therapeutic decision in case of positive diagnosis of hepatocellular carcinoma -patients with severe clotting alterations that contraindicate the fine-needle biopsy -Patients with chronic kidney disease or glomerular filtration rate < 30 ml/min - patients with contraindications to perform magnetic resonance imaging (pacemaker, claustrophobia...) - Known hypersensitivity to study drugs or excipients - pregnancy or breastfeeding |
- Pacientes con una función hepática deteriorada, cuya indicación terapéutica sería el trasplante hepático, incluso en ausencia de un CHC concomitante (Child-Pugh C) - Pacientes con antecedentes de CHC - Pacientes con comorbilidades que pudieran impedir una decisión terapéutica óptima en el caso de que fueran diagnosticados de un CHC - Pacientes con severos trastornos de la coagulación que pudieran contraindicar la realización de una PAF - Pacientes con insuficiencia renal crónica o con un filtrado glomerular <30 ml/min - Pacientes en los que la obtención de un estudio de RM esté contraindicado (pacientes con marcapasos, claustrofobia?) - Hipersensibilidad conocida a los medicamentos en estudio o a alguno de sus excipientes. - Embarazo o lactancia |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of hepatocellular carcinoma diagnosed using gadoxetic acid magnetic resonance imaging (accuracy for diagnosis) |
Proporción de diagnóstico de carcinoma hepatocelular a través de resonancia magnética usando ácido gadoxético como contraste (precisión diagnóstica) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- magnetic resonance imaging sensitivity - number of patients that need fine-needle biopsy to the diagnosis |
- sensibilidad de la resonancia magnética - número de pacientes que requieren punción con aguja fina para la realización de una biopsia confirmatoria de diagnóstico
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at the end of the study |
a la finalización del estudio |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
last vist of last patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |