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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥ 18 years old);

presenting with a symptomatic spontaneous supratentorial ICH;

ICH within 48 hours after symptoms onset (or last seen well);

ICH confirmed by brain imaging;

Disqualifiers

Massive ICH volume (≥ 60 ml) at admission;

Severe coma (defined as a Glasgow Coma Scale score < 6) at admission;

Planned neurosurgical hematoma evacuation;

Decision already taken for palliative care with withdrawal of active treatment;

Trial design

Design model

Single group

Treatments tested in this trial

  • TEP with 18F-DPA-714 injection

    Drug

    TEP with 18F-DPA-714 injection

Treatment groups

117 Participants
are divided into 1 treatment group
Group A: 18F-DPA-714 PET radiotracer uptake within the perihematomal edemaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) 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. * 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

Time frame
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH

Secondary outcomes

1

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

* 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

Time frame
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH o The functional outcome is measured at 6 months after ICH
2

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

* 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

Time frame
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Neurological deterioration is assessed within 14 days after ICH onset
3

18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the occurrence of early death

* 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.

Time frame
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Early death is assessed within 30 days after ICH onset.
4

18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the clinical outcome 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. * Clinical outcome at 6 months is assessed by the distribution of modified Rankin scale scores

Time frame
o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Clinical outcome is assessed et 6 months

Other outcomes

Sponsors and contacts

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