Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy (EPILITT)
3. oktober 2022 oppdatert av: Assistance Publique - Hôpitaux de Paris
Laser Induced Interstitial Thermal Therapy (LITT) is a "minimally invasive" procedure that uses the heat generated by a laser light (65°) to destroy brain lesions by coagulation leading to lesion necrosis under real-time MRI monitoring.
The laser optical fiber is implanted into the lesion using stereotaxy.
This technique, which can be performed under local anesthesia and on an outpatient basis, proved its efficacy and safety in the treatment of brain metastases for the first time in the world in 2006 (A.
Carpentier et al, 2008, 2011).
Since then, more than 5,000 patients have been treated in the USA, including for epileptogenic lesions (FDA device and CE cleared).
Our goal is to evaluate LITT on lesions with drug-resistant epilepsy for which surgical resection is impossible.
No therapeutic trial evaluating LITT in this indication has been performed to date.
It is therefore necessary to study its feasibility and tolerance.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
13
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Bertrand Mathon, MD
- Telefonnummer: 01 84 82 73 63
- E-post: bertrand.mathon@aphp.fr
Studiesteder
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Paris, Frankrike, 75013
- Rekruttering
- Hopital Pitie Salpetriere
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Ta kontakt med:
- Bertrand Mathon, MD
- Telefonnummer: +33 01 84 82 73 63
- E-post: bertrand.mathon@aphp.fr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age ≥18 years and < 80 years
- Patient with a medically unbalanced partial epilepsy
- Patient with a lesional image(s) in morphological MRI responsible for epilepsy based on clinical and electrophysiological assessment, +/- PET +/- SPECT +/- MEG +/- sEEG
- Patients for whom scheduled neurosurgical treatment with craniotomy appears difficult: Deep lesions, eloquent region lesions, patient reluctance to perform surgery.
- Endorsement of the Multidisciplinary Meeting of Neuro-epileptology
- Patient affiliated with a social security scheme
- Patient who has signed prior, free and informed consent
Exclusion Criteria:
- Pharmacosensitive epilepsy
- Patient with poor adherence to medication, or with psychological disorders
- Patients under legal protection
- Patient with a contraindication to MRI (metal shards, known allergy to gadolinium, etc.)
- Anticoagulant and antiplatelet therapy underway, cannot be stopped.
- Severe and unbalanced psychiatric disorders
- Pregnant women. Women of childbearing age should use oral contraception throughout the study.
- Allergy to local anaesthetics / general anaesthesia
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: LITT technology
Laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.
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One intervention : LITT (Laser Interstitial Thermal Treatment), technology that uses laser energy to thermally destroy (photo-thermal treatment) a brain injury under continuous MRI control (Validated by FDA - CE marking).
The operator console + surgical laser generator + software that manages the power delivered by the laser is connected to an MRI - Provided by MEDTRONIC - FDA approved and CE certified.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Frequency of post-surgical complication of grade greater or equal to 2 according to Mathon and al classification
Tidsramme: Day 30 post-operative
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To assess the safety and feasibility of laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.
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Day 30 post-operative
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Seizure freedom evaluated with Engel classification
Tidsramme: Post surgery : Month 1, Month 3, Month 6, Month 12
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Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.
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Post surgery : Month 1, Month 3, Month 6, Month 12
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Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification
Tidsramme: Post surgery : Month 1, Month 3, Month 6, Month 12
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Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications.
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Post surgery : Month 1, Month 3, Month 6, Month 12
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Number of seizure per patient
Tidsramme: Post surgery : Month 1, Month 3, Month 6, Month 12
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Evaluate the frequency of seizure
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Post surgery : Month 1, Month 3, Month 6, Month 12
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Number of patient with at least one seizure with complex partial seizure
Tidsramme: Post surgery : Month 1, Month 3, Month 6, Month 12
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Evaluate the intensity of seizure after treatment.
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Post surgery : Month 1, Month 3, Month 6, Month 12
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Number of patient at least one modification of anti-epileptic treatment
Tidsramme: Post surgery : Month 1, Month 3, Month 6, Month 12
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Evaluation of clinical efficacy of treatment
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Post surgery : Month 1, Month 3, Month 6, Month 12
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Mean change of quantification of the number of interictal peaks over 30 minutes evaluated at surface EEG compared to the pre surgery surface EEG
Tidsramme: Post surgery : Month 3, Month 6, Month 12
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Electrophysiological epileptic efficacy
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Post surgery : Month 3, Month 6, Month 12
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Mean change neuropsychological scores
Tidsramme: Post surgery : Month 12
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Evaluate the effect on cognition by a postoperative neuropsychological evaluation, compared with the pre-treatment neuropsychological evaluation.The neuro-psychological test will be selected according to the location of the lesion/focus
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Post surgery : Month 12
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Mean change in Quality of Life in Epilepsy (QOLIE-31) scores
Tidsramme: Post surgery : Month 6, Month 12
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Evaluate the effect on quality of life by comparing the preoperative assessment with the postoperative assessments.
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Post surgery : Month 6, Month 12
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Incidence of adverse events
Tidsramme: Day of surgery, Day 2, Day 7, Day 30 post-operative
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Evaluate the clinical tolerance of the procedure.
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Day of surgery, Day 2, Day 7, Day 30 post-operative
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Mean consumption of anti-epileptic drugs and epilepsy-related care
Tidsramme: Post surgery : Month 12
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To assess the medico-economic impact of the treatment
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Post surgery : Month 12
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Mean of major and minor axis measurements evaluated by measuring post-treatment morphological MRI images corresponding to induced necrosis in T1 gadolinium SPGR MRI
Tidsramme: Month 1, Month 3, Month 12
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Evaluate the radiological epileptic efficacy of treatment
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Month 1, Month 3, Month 12
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. juli 2022
Primær fullføring (Forventet)
15. september 2023
Studiet fullført (Forventet)
15. august 2024
Datoer for studieregistrering
Først innsendt
6. desember 2021
Først innsendt som oppfylte QC-kriteriene
17. januar 2022
Først lagt ut (Faktiske)
20. januar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. oktober 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. oktober 2022
Sist bekreftet
1. juli 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- APHP200097
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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