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Sonocloud-9 en asociación con carboplatino versus quimioterapias estándar de atención (CCNU o TMZ) en GBM recurrente (SONOBIRD)

2 de octubre de 2026 actualizado por: CarThera

Un ensayo pivotal aleatorizado, abierto, multicéntrico y de dos brazos de SonoCloud-9 combinado con carboplatino (CBDCA) frente a lomustina estándar (CCNU) o temozolomida (TMZ) en pacientes sometidos a resección planificada por glioblastoma de primera recurrencia.

The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

560

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Carole Desseaux
  • Número de teléfono: +33 472 626 268
  • Correo electrónico: contact@carthera.eu

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 10117
        • Reclutamiento
        • Charité Universitätsmedizin Berlin
        • Contacto:
          • Martin Misch, MD
      • Chemnitz, Alemania, 09113
        • Reclutamiento
        • Klinikum Chemnitz gGmbH
        • Contacto:
          • Sven-Axel May, MD
      • Cologne, Alemania
        • Reclutamiento
        • Neurochirurgie uniklinik Köln
        • Contacto:
          • Roland Goldbrunner, MD
      • Dresden, Alemania, 01307
        • Reclutamiento
        • Universitätsklinikum Carl Gustav Carus Dresden
        • Contacto:
          • Dietmar Krex, MD
      • Essen, Alemania, 45147
        • Reclutamiento
        • Universitätsklinikum Essen Klinik für Neurologie
        • Contacto:
          • Sied Kebir, MD
      • Münster, Alemania, 48149
        • Reclutamiento
        • University Hospital Munster
        • Contacto:
          • Walter Stummer, MD
  • Austria
      • Innsbruck, Austria, 6020
        • Reclutamiento
        • Medizinische Universitaet Innsbruck
        • Contacto:
          • Christian Freyschlag, MD
  • Bélgica
      • Brussels, Bélgica
        • Reclutamiento
        • Universitair Ziekenhuis Brussel
        • Contacto:
          • Duerinck Johnny, MD
      • Leuven, Bélgica
        • Reclutamiento
        • Universitair Ziekenhuis Leuven
        • Contacto:
          • Steven de Vleeschouwer, MD
      • Liège, Bélgica
        • Reclutamiento
        • CHU de Liège
        • Contacto:
          • Pierre Frères, MD
  • Dinamarca
      • Copenhagen, Dinamarca, 2100
        • Reclutamiento
        • Rigshospitalet
        • Contacto:
          • Jane Skjøth-Rasmussen, MD
      • Odense, Dinamarca, 5000
        • Reclutamiento
        • Odense University Hospital
        • Contacto:
          • Frantz Rom Poulsen, MD
  • España
      • Barcelona, España, 08035
        • Reclutamiento
        • Vall d'Hebron Institute of Oncology (VHIO)
        • Contacto:
          • Maria Vieito Villar, MD
      • Barcelona, España, 08036
        • Reclutamiento
        • Hospital Clinic de Barcelona
        • Contacto:
          • Jose Juan Gonzalez Sanchez, MD
      • Madrid, España
        • Reclutamiento
        • Hospital Universitario 12 de Octubre
        • Contacto:
          • Angel Perez-Nunez, MD
      • Madrid, España, 28050
        • Reclutamiento
        • Hospital Universitario HM Sanchinarro
        • Contacto:
          • Juan Manuel Sepulveda Sanchez, MD
      • Seville, España, 41013
        • Reclutamiento
        • Hospital Universitario Virgen del Rocío
        • Contacto:
          • Ignacio Martín Schrader, MD
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 805054
        • Reclutamiento
        • Mayo Clinic Arizona
        • Contacto:
          • Maciej Mrugala, MD
    • California
      • Los Angeles, California, Estados Unidos, 90095
        • Aún no reclutando
        • UCLA
        • Contacto:
          • Richard Everson, MD
      • Los Angeles, California, Estados Unidos, 90027
        • Aún no reclutando
        • Kaiser Permanente
        • Contacto:
          • Daniel Green, MD
      • San Francisco, California, Estados Unidos, 94143
        • Reclutamiento
        • University of California, San Francisco
        • Contacto:
          • Nicholas Butowski, MD
      • San Francisco, California, Estados Unidos, 94109
        • Reclutamiento
        • Sutter Health - California Pacific Medical Center
        • Contacto:
          • Lewis Leng, MD
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80011
        • Reclutamiento
        • UCHealth
        • Contacto:
          • Kevin Lillehei, MD
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224
        • Reclutamiento
        • Mayo Clinic of Jacksonville Florida
        • Contacto:
          • Kaisorn Chaichana, MD
      • Miami, Florida, Estados Unidos, 33176
        • Reclutamiento
        • Miami Cancer Institute
        • Contacto:
          • Michael Mc Dermott, MD
      • Tampa, Florida, Estados Unidos, 33612
        • Reclutamiento
        • Moffitt Cancer Center
        • Contacto:
          • James Liu, MD
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Reclutamiento
        • Winship Cancer Institute at Emory University
        • Contacto:
          • Edjah Nduom, MD
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Reclutamiento
        • Northwestern University
        • Contacto:
          • Rimas Lukas, MD
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Reclutamiento
        • Indiana University Health
        • Contacto:
          • Kathryn Nevel, MD
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Reclutamiento
        • John Hopkins University
        • Contacto:
          • Chetan Bettegowda, MD
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Activo, no reclutando
        • Mayo Clinic Rochester
    • New York
      • New York, New York, Estados Unidos, 10021
        • Reclutamiento
        • Weill Cornell Medicine
        • Contacto:
          • Rohan Ramakhrisna, MD
      • New York, New York, Estados Unidos, 10075
        • Reclutamiento
        • Lennox Hill Hospital
        • Contacto:
          • Randy D'Amico, MD
      • New York, New York, Estados Unidos, 10032
        • Reclutamiento
        • NewYork-Presbyterian / Columbia University Irving Medical Center
        • Contacto:
        • Contacto:
          • Brian JA Gill, MD
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27516
        • Reclutamiento
        • University of North Carolina
        • Contacto:
          • Carlos David, MD
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44106
        • Reclutamiento
        • Neurological Institute Brain Tumor Centre Taussig Cancer Cente
        • Contacto:
          • Matthew Grabowski, MD
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Reclutamiento
        • Penn State Health Milton S. Hershey Medical Center
        • Contacto:
          • Brad Zacharia, MD
    • Texas
      • Dallas, Texas, Estados Unidos, 75390
        • Reclutamiento
        • University of Texas Southwestern Medical Center
        • Contacto:
          • Toral Patel, MD
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • University of Texas Houston Health Science Center
        • Contacto:
          • Yoshua Esquenazi, MD
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Reclutamiento
        • University of Utah, Hunstman Cancer Institute
        • Contacto:
          • Randy Jenssen, MD
  • Francia
      • Bron, Francia
        • Reclutamiento
        • Hôpital Neurologique Pierre Wertheimer
        • Contacto:
          • François Ducray, MD
      • Marseille, Francia
        • Reclutamiento
        • Hôpital de La Timone
        • Contacto:
          • Olivier Chinot, MD
      • Paris, Francia
        • Reclutamiento
        • Hôpital de la Pitié-Salpêtrière
        • Contacto:
          • Ahmed Idbaih, MD
      • Suresnes, Francia, 92150
        • Reclutamiento
        • Hôpital Foch
        • Contacto:
          • Nadia Younan, MD
  • Italia
      • Bologna, Italia, 40139
        • Reclutamiento
        • Ospedale Bellaria
        • Contacto:
          • Enrico Franceschi, MD
      • Livorno, Italia, 57124
        • Reclutamiento
        • Ospedale Civile di Livorno
        • Contacto:
          • Anna Luisa Di Stefano, MD
      • Padua, Italia
        • Reclutamiento
        • Istituto Oncologico Veneto
        • Contacto:
          • Giuseppe Lombardi, MD
      • Roma, Italia
        • Reclutamiento
        • IFO - Istituto Nazionale Tumori Regina Elena
        • Contacto:
          • Veronica Villani, MD
      • Rozzano, Italia, 20089
        • Reclutamiento
        • Irccs Istituto Clinico Humanitas
        • Contacto:
          • Matteo Simonelli, MD
      • Torino, Italia, 10126
        • Reclutamiento
        • Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
        • Contacto:
          • Roberta Ruda, MD
  • Países Bajos
      • Rotterdam, Países Bajos
        • Reclutamiento
        • Erasmus Medisch Centrum (Erasmus MC)
        • Contacto:
          • Marjolein Geurts, MD
      • The Hague, Países Bajos, 2263
        • Reclutamiento
        • Haaglanden Medisch Centrum
        • Contacto:
          • Marike Broekman, MD
  • Suecia
      • Gothenburg, Suecia, 413 45
        • Reclutamiento
        • Sahlgrenska University Hospital
        • Contacto:
          • Louise Carstam, MD
      • Uppsala, Suecia, 75185
        • Reclutamiento
        • Akademiska sjukhuset
        • Contacto:
          • George Holgersson, MD
  • Suiza
      • Bern, Suiza, 3010
        • Reclutamiento
        • Inselspital Bern
        • Contacto:
          • Philippe Schucht, MD
      • Lausanne, Suiza, 1011
        • Reclutamiento
        • Centre Hospitalier Universitaire Vaudois (CHUV)
        • Contacto:
          • Andreas Hottinger, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry.

  2. Patient must have received prior first line therapy that must have contained both:

    1. Prior surgery or biopsy and standard fractionated radiotherapy (1.8-2 Gy/fraction, ≥56 Gy<66 Gy) or hypofractionated radiotherapy (15 x 2.66 Gy or similar regimen)
    2. One line of maintenance chemotherapy and/or immune- or biological therapy, (with or without Tumor-Treating Fields)

  3. First, unequivocal disease progression with

    1. measurable tumor (>100 mm2 or 1 cm3, based on RANO criteria) documented (e.g., increase of 25% in tumor diameter) on MRI and,
    2. interval of a minimum of 12 weeks since the completion of prior radiotherapy, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling

  4. Patient is a candidate for craniotomy and at least 50% resection of enhancing region

  5. Maximal enhancing tumor diameter prior to inclusion ≤ 5 (+7%) cm on T1w on MRI performed within 14 days prior to inclusion§. (In case of planned lobectomy, post operative peritumoral brain or residual size ≤5 cm)

  6. WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) ≥ 70)

  7. Age ≥ 18 years

  8. Participant must be recovered from acute toxic effects (≤ grade 2) of all prior anticancer therapy. Interval since last therapy to presumed date of surgery of at least:

    1. ≥ 4 weeks or 5 half-lives (whichever is shorter) for

      • Cytotoxic
      • Other small chemical entity (e.g., targeted therapy)
      • For biologics (e.g., antibodies, except bevacizumab)

    2. ≥ 6 weeks of prior bevacizumab

  9. Adequate hematologic, hepatic, and renal laboratory values within 14 days prior to inclusion§ i.e.:

    1. Hemoglobin ≥ 10 g/dL, platelets ≥ 100,000/mm3, neutrophils ≥ 1500/mm3.
    2. Liver function test with ≤ grade 1 alterations, except if due to antiepileptic drug therapy or isolated increased bilirubin due to Gilbert syndrome
    3. Estimated glomerular filtration rate (eGFR) of at least 60 mL/min/m2 using Appendix 12.4 formula
    4. AST(SGOT)/ALT(SPGT) ≤ 3 X institutional ULN (upper Limit of Normal)

  10. Patient able to understand clinical trial information and willing to provide signed and informed consent

  11. Patient of childbearing potential must have a negative pregnancy test within 14 days prior to inclusion§ and must agree to use a medically-acceptable method of birth control during the treatment period and, if randomized in the experimental arm, for at least 1 month after the last cycle of carboplatin

  12. A male patient must agree to use condoms during the treatment period and, if randomized in the experimental arm, for at least 3 months after the last cycle of carboplatin; the patient must also refrain from donating sperm during this period.

  13. Patient must be a beneficiary of a health plan that covers routine patient care costs. Patient must be a beneficiary of or affiliated with a social security scheme (according to country-specific requirements)

(§) These exam/lab tests could be (re)evaluated before randomization if the corresponding selection criteria could not be fully met at time of inclusion. If not met before randomization, the patient will be considered as screen failure.

Non-Inclusion Criteria:

  1. Multifocal enhancing tumor on T1w (unless all localized in a 5 cm diameter area)
  2. Posterior fossa tumor
  3. Known BRAF/ NTKR mutated patients
  4. Patient at risk of surgery site infection (e.g., 2 or more previous craniotomies/neurosurgery within the last 3 months, poor skin condition, known impaired wound healing and/or previously infected surgical field, uncontrolled diabetes or any other condition that is of increased infectious risk in the opinion of the neurosurgeon)
  5. Patient treated at high, stable -or average- dose of corticosteroids (≥ 6 mg/day dexamethasone or equivalent) in the 7 days prior to inclusion. Patients on dexamethasone for reasons other than mass effect may still be enrolled.
  6. Contra-indication to carboplatin, CCNU or TMZ
  7. Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in ultrasound resonator
  8. Patient has received bevacizumab for other reasons (such as tumor progression) than treating edema
  9. Peripheral neuropathy or neuropathy ≥ grade 2
  10. Uncontrolled epilepsy or evidence of intracranial pressure
  11. Patient with known intracranial aneurism or having presented intra-tumor significant spontaneous hemorrhage
  12. Patient with unremovable coils, clips, shunts, intravascular stents, and/or wafer, or reservoirs
  13. Patient with medical need to be on continued anti-platelet aggregation therapy and/or anticoagulation. Patients for whom anticoagulation/platelet aggregation can be temporarily interrupted may be eligible after discussion and prior authorization by the sponsor.
  14. Patient receiving enzyme-inducing antiepileptic drugs (namely phenytoin, carbamazepine and derivatives, phenobarbital), unless switched on another antiepileptic regimen
  15. History of other malignancy within 3 years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine cervix
  16. Patient with known or suspected active or chronic infections
  17. Patient with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mm Hg), uncontrolled systemic hypertension, or acute respiratory distress syndrome
  18. Known sensitivity/allergy to gadolinium, or other intravascular contrast agents
  19. Patient with impaired thermo-regulation or temperature sensation
  20. Pregnant, or breastfeeding patient
  21. Any other serious patient medical or psychological condition that may interfere with adequate and safe delivery of treatment and care (e.g., positive human immunodeficiency virus [HIV] status, potential blood-borne infections, malnutrition…), circumstance (e.g., sinus opening during surgery), psychological, morphological characteristics (e.g., skin characteristics, bone thickness), or any pre-existing comorbidities that in the investigator's opinion may prevent the implantation of the device, may impair the ability of the patient to receive treatment with SonoCloud-9 or may be confounding for evaluation of the clinical trial endpoints
  22. Patients under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision

Exclusion Criterion:

Occurrence of any major medical illnesses or impairments that in the Investigator's opinion may hampered the ability of the patient to receive treatment with SonoCloud-9 or may be confounding for evaluation of the clinical endpoints.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental Arm: SonoCloud-9 Ultrasound + Carboplatin

The SonoCloud-9 (SC9) device will be implanted in the skull bone window upon completion of tumor resection and routine craniotomy. Carboplatin (CBDCA) will be administered intravenously prior to sonication. The CBDCA/SC9 treatment will be repeated every 3 weeks (depending on patient's tolerability) until disease progression or as clinically indicated. Administration of up to 7 cycles is planned.
Dispositivo: SonoCloud-9 (SC9)

Implantation of SC9 device and repeat activation at constant acoustic pressure

Droga: Carboplatin

Dose of carboplatin AUC 5 mg/ml.min-1 calculated using Calvert's formula:

Dose (mg) = target AUC (mg/mL x minute) x [glomerular filtration rate (GFR) mL/minute + 25].

Otros nombres:
  • Ácido ciclobutano dicarboxílico (CBDCA)
Comparador activo: Control Arm: SoC single agent chemotherapy TMZ or CCNU

Standard of Care (SoC) treatment with either temozolomide (TMZ) or lomustine (CCNU).

Standard TMZ chemotherapy as a single oral dose every 4 weeks for up to 6 cycles.

Standard CCNU chemotherapy as a single oral dose every 6 weeks for up to 4 cycles.
Droga: Lomustine

Dosed and administered per labelling.

Otros nombres:
  • 1-(2-cloroetil)-3-ciclohexil-1-nitrosourea (CCNU)
Droga: Temozolomide

Dosed and administered per labelling.

Otros nombres:
  • Temodal

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall survival (OS)
Periodo de tiempo: Up to 24 months

Survival status will be collected during the treatment period, for up to 7 months (short-term follow-up) and then every 3 months as standard of care follow-up (long-term follow-up) until participant's 'End of Study', defined as end of survival follow-up period, death, withdrawal of consent for the collection of data, or 'lost to follow-up' (whichever comes first).
Up to 24 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Tumor Growth Rate
Periodo de tiempo: Up to week 24

Tumor Growth Rate will be determined by measuring hyperintense tumor volume using T1w contrast-enhancing tumor-related region from post-surgery MRI baseline to unequivocal progression MRI (i.e., suspected radiologic progression confirmed by repeat scan).
Up to week 24
Progression Free Survival (PFS)
Periodo de tiempo: Up to 24 months

Defined as the time from date of randomization to the earlier of the following events: unequivocal tumor progression as determined by IRC per RANO criteria or death due to any cause.
Up to 24 months
Overall survival at 12 months (OS12)
Periodo de tiempo: 12 months

Defined as the proportion of participants alive at 12 months
12 months
Overall survival at 18 months (OS18)
Periodo de tiempo: 18 months

Defined as the proportion of participants alive at 18 months
18 months
Progression-free survival at 6 months (PFS6)
Periodo de tiempo: 6 months

Defined as the proportion of participants without disease progression or death due to any cause at 6 months.
6 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety and Tolerability
Periodo de tiempo: Up to week 24

Frequency and severity of adverse events scored according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, from surgery to End-of-Trial Intervention visit
Up to week 24

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

CarThera

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

29 de enero de 2024

Finalización primaria (Estimado)

28 de enero de 2028

Finalización del estudio (Estimado)

30 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

5 de junio de 2023

Primero enviado que cumplió con los criterios de control de calidad

5 de junio de 2023

Publicado por primera vez (Actual)

13 de junio de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de octubre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • SC9-GBM-03
  • 2023-505829-14-00 (Otro identificador: EU CT Number)
  • 2023 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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