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18F-DPA714 PET-MRI study to improve preoperative localisation of the epileptic focus to be resected in drug-resistant partial epilepsy.

Key facts

Where
Orsay Cedex, FranciaországSee the site
Phase
1. fázis

Where in Franciaország

  • Commissariat A L'energie Atomique Et Aux Energies AlternativesOrsay Cedex, FranciaországNo longer taking part

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Trial details

Who runs it
Commissariat a l'Energie Atomique et aux Energies Alternatives
Trial code
EU 2024-517638-16-00
Record updated
2024. november 4.
Original description
To evaluate the contribution of 18F-DPA-714 PET imaging in locating the seizure zone in patients aged 12 and over with drug-resistant partial epilepsy who are candidates for surgery during their phase 2 work-up.Read full original descriptionShow less

18F-DPA714 PET-MRI study to improve preoperative localisation of the epileptic focus to be resected in drug-resistant partial epilepsy

To evaluate the contribution of 18F-DPA-714 PET imaging in locating the seizure zone in patients aged 12 and over with drug-resistant partial epilepsy who are candidates for surgery during their phase 2 work-up.

Inclusion: FOR PATIENTS: Patients with drug-resistant epilepsy (whose epilepsy epilepsy persists after two types of well-conducted treatment); FOR PATIENTS: Male or female ; FOR PATIENTS: Age : ≥ 12 years; FOR PATIENTS: Patients with drug-resistant partial epilepsy who have undergone a pre-surgical assessment or phase 1 , the results of which necessitate the use of a SEEG; FOR HEALTHY VOLUNTEER: Healthy volunteers (i.e. no chronic and/or progressive general pathology); FOR HEALTHY VOLUNTEER: Male or female; FOR HEALTHY VOLUNTEER: Age: ≥ 18 years and up to 55 years; FOR HEALTHY VOLUNTEER: Social security.

Exclusion: FOR PATIENTS: Treatment with benzodiazepines such as flunitrazepam, triazolam, diazepam, which may have a moderate affinity for TSPO, be prohibited and must be discontinued at least 15 days before inclusion in the study. Clonazepam, lorazepam, zolpidem, and zopiclone, which have a very low affinity for TSPO, will be tolerated tolerated like other GABA A receptor-modulating antiepileptics; FOR PATIENTS: Any contraindication to MRI; FOR PATIENTS: Pregnant or lactating women, or those not using effective contraception; FOR PATIENTS: Lying position impossible to maintain for long periods; FOR PATIENTS: Patients already included in another therapeutic trial using radioactivity; FOR HEALTHY VOLUNTEER: Any contraindication to MRI; FOR HEALTHY VOLUNTEER: Women who are pregnant, lactating or not using an effective method of contraception; FOR HEALTHY VOLUNTEER: Lying position impossible to maintain for long periods; FOR HEALTHY VOLUNTEER: Subject excluded from a medical research protocol.

EU CTIS 2024-517638-16-00