2024-517638-16-00CompletedPhase 1
18F-DPA714 PET-MRI study to improve preoperative localisation of the epileptic focus to be resected in drug-resistant partial epilepsy.
18F-DPA714 PET-MRI study to improve preoperative localisation of the epileptic focus to be resected in drug-resistant partial epilepsy
Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 3 Oct 2024
- Start date
- 4 Nov 2024
- Lead sponsor
- Commissariat a l'Energie Atomique et aux Energies Alternatives
- Diseases
- Epilepsy
- EU CT number
- 2024-517638-16-00
- EudraCT number
- 2017-003381-27
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 50
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: - to 64 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Commissariat A L'energie Atomique Et Aux Energies Alternatives | Orsay Cedex | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.