- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06863324
Impacto de la radiosensibilidad individual en las toxicidades tardías de la radiocirugía en la neuralgia del trigémino esencial (TRITON)
Trigeminal neuralgia is intense, electric-shock-like facial pain, most often triggered by touch, chewing or speech. It results from dysfunction of the trigeminal nerve, the 5th cranial nerve. In most cases, no cause is found, and trigeminal neuralgia is termed "essential". In the first instance, treatment is based on medication. In cases of drug resistance, radiosurgery is a possible treatment option. This involves performing neurolysis, delivering a very high dose of ionizing radiation to the trigeminal nerve. The immediate success rate of radiosurgery is 80-90%.
However, in the long term, around 30% of patients experience complications (mainly hypoesthesia of the face on the treated side, paresthesias, masticatory disorders, neuropathic pain) and 30% of patients experience a recurrence of neuralgic pain. Most of these complications are permanent, and there are very few effective treatments, either medical or physical. Recurrence and complications are correlated, i.e. patients with hypoesthesia have a lower risk of recurrence. Certain technical parameters are associated with the efficacy and toxicity of radiosurgery, notably the position of the point of impact of the rays on the nerve. However, for identical treatment techniques, there are currently no known prognostic criteria for the efficacy and toxicity of radiosurgery.
Numerous radiobiological studies have demonstrated that sensitivity to ionizing radiation differs from one individual to another, with each person having his or her own tolerance threshold. Indeed, 5-10% of patients are hypersensitive to ionizing radiation and are at very high risk of developing late complications [Bentzen et al. 2010]. There are currently commercial tests for individual radiosensitivity, based on a simple blood test, whose clinical value has been demonstrated in predicting complications in patients irradiated for breast or prostate cancer. These tests are based on the rate of radiation-induced lymphocyte apoptosis, known as the RILA (Radiation Induced Lymphocyte Apoptosis) score. Numerous teams have shown retrospectively and then prospectively that a high RILA score is significantly correlated with the absence of the development of radiation-induced late adverse events, with a negative predictive value of over 90% (level of evidence 1) [Azria et al. 2015; Mirjolet et al. 2016; Talbot et al. 2019]. In practical terms, the test gives a lymphocyte apoptosis score for each patient. A cut-off point is set below which the patient is considered "radiation hypersensitive".
In this study, the investigators propose to correlate the RILA score with the occurrence of severe late toxicity in patients treated by radiosurgery for trigeminal neuralgia.
In the event of a positive result, this would make it possible either to adapt the radiosurgery technique to minimize the risk of late complications, or to contraindicate radiosurgery and refer patients to other treatment methods.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients ≥ 18 years of age
- Patients treated for trigeminal neuralgia by radiosurgery at CHPG more than 12 months ago
- Treatment of the nerve with a 4 or 5 mm cone
- Patient affiliated to social security
- Patient agreement: obtaining the patient's non-opposition (France) or consent (Monaco)
Exclusion Criteria:
- Patients pre-treated for neuralgia by another invasive method: thermo coagulation, decompression surgery, radiosurgery...
- Patients with multiple sclerosis (MS)
- Secondary neuralgia
- Hypoesthesia pre-existing treatment
- Protected persons: persons deprived of their liberty, patients under guardianship or trusteeship
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: patients with trigeminal neuralgia treated by radiosurgery
patient with trigeminal neuralgia, treated by radiosurgery |
Diagnostic test for estimation of individual radiosensitivity, based on blood test, whose clinical value has been demonstrated in predicting complications in patients irradiated for breast or prostate cancer. These tests are based on the rate of radiation-induced lymphocyte apoptosis, known as the RILA (Radiation Induced Lymphocyte Apoptosis) score |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlate RILA score to the occurrence of severe hypoesthesia following radiosurgery for treatment of trigeminal neuralgia.
Periodo de tiempo: 18 months after radiosurgery
|
Evaluation of the probability of occurrence of severe late toxicity, i.e. hypoesthesia grade BNI III or IV after 18 months, in patients with low-risk RILA score (score between 21 and 100% lymphocyte apoptosis) vs. high-risk RILA score (score between 0 and 20% lymphocyte apoptosis). |
18 months after radiosurgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlate RILA score with radiosurgery efficacy
Periodo de tiempo: 18 months after radiosurgery
|
Evaluation of the probability of radiosurgery failure (treatment failure or neuralgia recurrence) in patients with low-risk RILA score vs. high-risk RILA score |
18 months after radiosurgery
|
|
Correlate RILA score to trigeminal nerve hypersignal on postradiosurgery MRI
Periodo de tiempo: 18 months after radiosurgery
|
Correlation between RILA score and presence of trigeminal nerve hypersignal on MRI performed 6 months after radiosurgery. |
18 months after radiosurgery
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 24-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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