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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Commissariat a l'Energie Atomique et aux Energies Alternatives

Participant type

Pediatric, Patients, Healthy volunteers

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

4 Nov 2024 → ongoing

Decision date (initial)

2024-11-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517638-16-00

EudraCT number

2017-003381-27

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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.

Secondary objectives 8

1. Evaluate the feasibility and tolerance of the entire procedure.
2. Evaluate the efficacy at 1 year of surgical intervention in the event of removal of the focus designated by imaging.
3. Study the influence of “epilepsy type” (location, etiology) on imaging results.
4. Study the factors associated with surgical failure in relation to imaging data.
5. Compare the volume resected in surgery with the volume defined on the basis of imaging results.
6. To study the imaging results of patients rejected after SEEG.
7. To compare the topography of the data from the 18F-DPA-714 PET imaging data with those of MRI imaging (diffusion tensor and T1 and T2 morphological MRI).To compare the topography of the data from the 18F-DPA-714 PET imaging.
8. Assessment of the impact of the epileptic focus on remote brain function brain function (resting-state functional MRI).

Conditions and MedDRA coding

Patients with drug-resistant epilepsy who are candidates for surgery requiring SEEG.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. FOR PATIENTS: Patients with drug-resistant epilepsy (whose epilepsy epilepsy persists after two types of well-conducted treatment).
2. FOR PATIENTS: Male or female .
3. FOR PATIENTS: Age : ≥ 12 years
4. 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
5. FOR HEALTHY VOLUNTEER: Healthy volunteers (i.e. no chronic and/or progressive general pathology)
6. FOR HEALTHY VOLUNTEER: Male or female
7. FOR HEALTHY VOLUNTEER: Age: ≥ 18 years and up to 55 years
8. FOR HEALTHY VOLUNTEER: Social security

Exclusion criteria 9

1. FOR PATIENTS: Any contraindication to MRI.
2. FOR PATIENTS: Pregnant or lactating women, or those not using effective contraception.
3. FOR PATIENTS: Lying position impossible to maintain for long periods.
4. 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.
5. FOR PATIENTS: Patients already included in another therapeutic trial using radioactivity.
6. FOR HEALTHY VOLUNTEER: Any contraindication to MRI
7. FOR HEALTHY VOLUNTEER: Women who are pregnant, lactating or not using an effective method of contraception
8. FOR HEALTHY VOLUNTEER: Lying position impossible to maintain for long periods
9. FOR HEALTHY VOLUNTEER: Subject excluded from a medical research protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of subjects in whom the epileptogenic volume defined by SEEG performed according to the electrode implantation plan determined with multimodal PET-MRI imaging (VE2) will have been correctly modified compared with the electrode implantation plan determined without multimodal imaging data (VE1).

Secondary endpoints 8

1. Collection and analysis of adverse events and their causal relationship in relation to the entire procedure evaluated.
2. Number of subjects who benefited from the entire procedure in accordance with the protocol.
3. Number of seizures in patients 1 year after surgery (ILAE classification).
4. Study of imaging results in subgroups of patients according to the type epilepsy (temporal or extra-temporal localization, etiology of epilepsy epilepsy, seizure frequency).
5. Imaging data in patients not cured by surgery.
6. Imaging data in patients rejected after SEEG.
7. Topography of PET imaging data 18F-DPA-714 PET vs. MRI data.
8. Relationship between epileptic focus and remote brain function.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Commissariat a l'Energie Atomique et aux Energies Alternatives

Sponsor organisation

Commissariat a l'Energie Atomique et aux Energies Alternatives

Address

4 Place Du General Leclerc

City

Orsay Cedex

Postcode

91401

Country

France

Scientific contact point

Organisation

Commissariat a l'Energie Atomique et aux Energies Alternatives

Contact name

Viviane BOUILLERET

Public contact point

Organisation

Commissariat a l'Energie Atomique et aux Energies Alternatives

Contact name

Viviane BOUILLERET

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications