- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06863324
Impact de la radiosensibilité individuelle sur les toxicités tardives de la radiochirurgie dans la névralgie du trijumeau essentiel (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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Correlate RILA score to the occurrence of severe hypoesthesia following radiosurgery for treatment of trigeminal neuralgia.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Correlate RILA score with radiosurgery efficacy
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 24-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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