Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Role of Neuroinflammation and Blood-Brain Barrier Breakdown in Intracerebral Hemorrhage. (INFINITE)

6 maja 2026 zaktualizowane przez: University Hospital, Toulouse
In this prospective, multicenter study of patients with acute spontaneous supratentorial Intracerebral Hemorrhage (ICH), each participant will have a standardized multimodal evaluation of neuroinflammation at 10 (±2) days after onset including translocator protein 18 kDa (TSPO) positron emission tomography (PET) using 18F-DPA-714 radioligand, BBB imaging using Dynamic contrast-enhanced (DCE)-MRI and a panel of pro-inflammatory and anti-inflammatory plasma biomarkers.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Intracerebral Hemorrhage (ICH) is the most devastating stroke subtype that affects > 3 million people worldwide each year. Despite important efforts and the hope that minimally invasive surgical procedures may offer, there is currently no effective treatment. Perihematomal edema - a surrogate marker of neuroinflammation - has emerged as important contributors to poor functional outcome following acute ICH, and a potential treatment target. Innovative techniques have been developed to image and measure neuroimmune response (TSPO PET) and BBB integrity (DCE-MRI). These novel methods have been poorly studied in ICH. The effects of in vivo perihematomal neuroinflammation on the functional outcome of patients with acute ICH is widely unknown.

The present study is a prospective, multicenter study of patients with acute spontaneous supratentorial ICH (within 48h after onset). Each participant will have a standardized multimodal evaluation of neuroinflammation at 10 days after onset including TSPO PET using 18F-DPA-714 radioligand, BBB imaging using DCE-MRI and a panel of pro-inflammatory and anti-inflammatory plasma biomarkers.

In hospital follow up visit will occur at 14 days and end of follow up visit at 180 days. Functional outcome will be assessed by modified Rankin scale (mRS), which is a widely used and validated scale - ranging from 0 (no symptoms) to 6 (death) - to evaluate the functional outcome following ischemic or hemorrhagic strokes.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

117

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Francja
      • Bordeaux, Francja, 33000
      • Montpellier, Francja, 34000
      • Toulouse, Francja, 31000

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. Adults (≥ 18 years old);
  2. presenting with a symptomatic spontaneous supratentorial ICH;
  3. ICH within 48 hours after symptoms onset (or last seen well);
  4. ICH confirmed by brain imaging;
  5. Informed consent documented;
  6. Affiliated or beneficiary of social security scheme.

Exclusion Criteria:

  1. Massive ICH volume (≥ 60 ml) at admission;
  2. Severe coma (defined as a Glasgow Coma Scale score < 6) at admission;
  3. Planned neurosurgical hematoma evacuation;
  4. Decision already taken for palliative care with withdrawal of active treatment;
  5. Pre-existing dependance defined as a mRS score ≥2 prior to ICH occurrence;
  6. Underlying secondary cause of ICH including macrovascular causes (brain arteriovenous malformation, intracranial aneurysm, dural arteriovenous fistula, cavernous malformation), brain tumour, cerebral venous thrombosis, hemorrhagic infarction. Patients taking oral anticoagulant can be included;
  7. TSPO genotyping demonstrating a low affinity binder profile,
  8. Unable to tolerate or contraindicated to brain MRI: medical material not MRI compatible, claustrophobia, known hypersensitivity to gadoteric acid, meglumin or any drug containing gadolinium;
  9. Estimated glomerular filtration rate < 30 ml/min/1.73 m 2
  10. Unable to tolerate or contraindicated to 18F-DPA714 PET: women who are pregnant or breastfeeding, claustrophobia, and known hypersensitivity to DPA-714;
  11. Use of Benzodiazepines within 7 days (within 6 weeks for prazepam, diazepam or clorazepate) preceding TSPO PET acquisition;
  12. Co-existing neuroinflammatory disease such as Multiple Sclerosis, Neuromyelitis optica, Neurosarcoidosis, autoimmune encephalitis, CNS vasculitis;
  13. Conditions requiring long-term immunosuppressive medication;
  14. Expected impossible follow-up or poor compliance;
  15. Patient under tutorship, curatorship, or legal protection.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 18F-DPA-714 PET radiotracer uptake within the perihematomal edema
18F-DPA-714 injection for TEP
Lek: TEP with 18F-DPA-714 injection
TEP with 18F-DPA-714 injection

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months
Ramy czasowe: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH
  • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
  • The functional outcome at 6 months after ICH is quantified by the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]). Poor functional outcome is defined as a modified Rankin scale score (mRs) ≥3
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Volume of brain tissue with increased 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months
Ramy czasowe: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH o The functional outcome is measured at 6 months after ICH
  • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR). Volume of brain tissue (mL) with increased 18F-DPA-714 binding is measured in the area around the hematoma.
  • The functional outcome at 6 months after ICH is quantified by the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]). Poor functional outcome is defined as a modified Rankin scale score (mRs) ≥3
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH o The functional outcome is measured at 6 months after ICH
18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the occurrence of neurological deterioration within 14 days after ICH onset
Ramy czasowe: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Neurological deterioration is assessed within 14 days after ICH onset
  • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
  • Neurological deterioration within 14 days after ICH onset is defined as a ≥4-point increase on the National Institutes of Health Stroke Scale (NIHSS) or ≥2-point decrease on the Glasgow Coma Scale (GCS) compared to baseline scores at the pre-inclusion visit
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Neurological deterioration is assessed within 14 days after ICH onset
18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the occurrence of early death
Ramy czasowe: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Early death is assessed within 30 days after ICH onset.
  • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
  • Early death is defined as death at day 30 after ICH onset.
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Early death is assessed within 30 days after ICH onset.
18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the clinical outcome at 6 months
Ramy czasowe: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Clinical outcome is assessed et 6 months
  • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
  • Clinical outcome at 6 months is assessed by the distribution of modified Rankin scale scores
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Clinical outcome is assessed et 6 months
18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the mortality
Ramy czasowe: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Mortality is assessed at 6 months.
  • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
  • Mortality is assessed at 6 months.
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Mortality is assessed at 6 months.
Correlations of 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH with MRI-derived measures of BBB breakdown and plasma levels of inflammatory biomarkers
Ramy czasowe: PET, MRI and plasma inflammatory biomarkers measures are evaluated at day 10 ±2 after ICH onset
  • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
  • BBB breakdown is quantified by MRI-derived quantitative measures based on maps of the contrast agent transfer coefficient (Ktrans) in the perihematomal area at day 10 ±2 after ICH;
  • Plasma levels of inflammatory biomarkers (including MMP9, TNF alpha, , IL-6 and -10, soluble TLR 2/4, Neutrophil Extracellular Traps (NETs) are measured at day 10 ±2 after ICH onset.
PET, MRI and plasma inflammatory biomarkers measures are evaluated at day 10 ±2 after ICH onset
BBB breakdown at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months
Ramy czasowe: o MRI-derived quantitative measures of BBB breakdown are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.
  • BBB breakdown is quantified by MRI-derived quantitative measures based on maps of the contrast agent transfer coefficient (Ktrans) in the perihematomal area at day 10 ±2 after ICH;
  • The functional outcome at 6 months after ICH is quantified by the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]). Poor functional outcome is defined as a modified Rankin scale score (mRs) ≥3
o MRI-derived quantitative measures of BBB breakdown are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.
Plasma levels of inflammatory biomarkers at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months
Ramy czasowe: o Plasma inflammatory biomarkers measures are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.
  • Plasma levels of inflammatory biomarkers (including MMP9, TNF alpha, , IL-6 and -10, soluble TLR 2/4, Neutrophil Extracellular Traps (NETs) are measured at day 10 ±2 after ICH onset;
  • The functional outcome at 6 months after ICH is quantified by the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]). Poor functional outcome is defined as a modified Rankin scale score (mRs) ≥3
o Plasma inflammatory biomarkers measures are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University Hospital, Toulouse

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 września 2029

Ukończenie studiów (Szacowany)

1 grudnia 2029

Daty rejestracji na studia

Pierwszy przesłany

26 stycznia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RC31/24/0443
  • 2025-521923-58-00 (Ctis)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na TEP with 18F-DPA-714 injection

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Switzerland

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj