Dravet Sendromlu Hastalarda Beyin Sapı Serotonerjik Yolağının PET-MR Görüntüleme Çalışması

Sade dilde özet

Bu çalışma, Dravet sendromu (Dravet syndrome, ağır bir epilepsi türü) olan hastalarda beyin sapındaki serotonerjik yolağı [18F]MPPF adlı işaretleyici ile PET-MR görüntüleme kullanarak incelemektedir. Çalışmaya, 18 yaş ve üzeri, genetik testle Dravet sendromu tanısı doğrulanmış yetişkin hastalar ile karşılaştırma grupları katılabilmektedir. Çalışma faz uygulanmayan bir araştırma olarak yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Katılımcı alıyor

Sponsor

Hospices Civils de Lyon

Müdahale

[18F]MPPF PET-MRI

Başlangıç

04.05.2026

Tahmini bitiş

04.01.2028

Ülkeler

France

İlgili genler

Merkezler

• Bron, France

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Patients with DS

* Inclusion criteria

  1. Adult patients (≥ 18 but \< 60 years)
  2. Diagnosis of Dravet syndrome will be confirmed based on medical history, type of seizures, EEG data and results of genetic testing
  3. No restriction related to the seizure frequency
  4. Patient assent and patient (or patient's legal representative guardianship) who gave its written informed consent to participate to the study
  5. For women of childbearing
* Exclusion criteria

  1. Subject in exclusion period of another study
  2. MRI contra-indication (presence of metallic elements, claustrophobia, Patients unable to maintain a minimul level of immobility during the imaging acquisition)
  3. Presence of Vagal Nerve Stimulation
  4. Patients unable to maintain a minimul level of immobility during the imaging acquisition
  5. Pregnant women, women in labor or breastfeeding women.
  6. Severe renal failure (Glomerular filtration rate \< 30 ml/min)
  7. Hypersensitivity to \[18F\] MPPF
  8. Persons deprived of their liberty by a judicial or administrative decision
  9. Persons under psychiatric care
  10. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Patients with drug-resistant focal epilepsy

* Inclusion criteria

  1. Adult patient (≥ 18 years)
  2. Patient suffering from drug-resistant focal epilepsy according to ILAE classification
  3. Patient in whom presurgical evaluation is considered
  4. No restriction related to the seizure frequency
  5. Patient who gave her/his written informed consent to participate to the study
  6. For women of childbearing potential, use highly effective contraception during study participation
* Exclusion criteria

  1. Subject in exclusion period of another study
  2. MRI contra-indication (presence of metallic elements, claustrophobia)
  3. Presence of Vagal Nerve Stimulation
  4. Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor
  5. Pregnant women, women in labor or breastfeeding women.
  6. Severe renal failure (Glomerular filtration rate \< 30 ml/min)
  7. Hypersensitivity to \[18F\] MPPF
  8. Persons deprived of their liberty by a judicial or administrative decision
  9. Persons under psychiatric care
  10. Persons admitted to a health or social institution for purposes other than research
  11. Adults subject to a legal protection measure (guardianship, curatorship)
  12. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Healthy controls

* Inclusion criteria

  1. Presence of the symptoms of anxiety and/or depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS)
  2. Ongoing treatment with selective serotonin reuptake inhibitor
  3. MRI contra-indication (presence of metallic elements, claustrophobia)
  4. Pregnant women, women in labor or breastfeeding women.
  5. Severe renal failure (Glomerular filtration rate \< 30 ml/min)
  6. Hypersensitivity to \[18F\] MPPF
  7. Persons deprived of their liberty by a judicial or administrative decision
  8. Persons under psychiatric care
  9. Persons admitted to a health or social institution for purposes other than research
  10. Adults subject to a legal protection measure (guardianship, curatorship)
  11. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
* Exclusion criteria

  1. Presence of the symptoms of anxiety and/or depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS)
  2. Ongoing treatment with selective serotonin reuptake inhibitor
  3. MRI contra-indication (presence of metallic elements, claustrophobia)
  4. Pregnant women, women in labor or breastfeeding women.
  5. Severe renal failure (Glomerular filtration rate \< 30 ml/min)
  6. Hypersensitivity to \[18F\] MPPF
  7. Persons deprived of their liberty by a judicial or administrative decision
  8. Persons under psychiatric care
  9. Persons admitted to a health or social institution for purposes other than research
  10. Adults subject to a legal protection measure (guardianship, curatorship)
  11. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme