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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01619709
Other study ID # 11 223 02
Secondary ID AOL 2011
Status Completed
Phase N/A
First received
Last updated
Start date January 2012
Est. completion date June 2017

Study information

Verified date September 2018
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage (probably related to hypertension).


Description:

Cerebral Amyloid Angiopathy (CAA) and hypertension related hemorrhage are the main causes of non traumatic primary intracerebral hemorrhage. In vivo diagnosis of these two cerebral diseases may be difficult and is based on hematoma location and pattern of cerebral microbleeds (CMB) distribution. We aimed to evaluate a multimodal approach including brain MRI, Pet AV-45 Amyloid imaging and neuropsychological assessment to improve etiological diagnosis of primary intracerebral hemorrhage. 70 patients with acute primary non traumatic intracerebral hemorrhage will be prospectively included and two groups will be compared: lobar hemorrhage group and deep hemorrhage group. Brain MRI, Pet AV-45 Cerebral Amyloid imaging (during the first month) and neuropsychological assessment (Three months later) are performed. Differences between the two groups are evaluated for AV45 cortical binding, CMB distribution, White Matter Lesions and cognitive profile.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria:

- Age : 40-90 years,

- Non traumatic primary intracerebral hemorrhage during acute phase (less than 30 days from hemorrhage onset) confirmed on brain imaging (CT and/or MRI).

- Correct visual, hearing and language functions to perform neuropsychological tests.

- Written consent of patient

Exclusion Criteria:

- Secondary causes of intracerebral hemorrhage : vascular malformations (Arteriovenous malformation, intracranial aneurysm, Cavernous angioma, dural arteriovenous fistula), cerebral venous thrombosis, intracranial neoplasm, coagulopathy, vascularitis, Cocaine or alcohol use, Hemorrhagic ischemic stroke.

- Pregnancy

- Contraindication to MRI

- progressive neoplasm

- Cognitive impairment secondary to progressive neurological disease

- Depression,

- Drug addiction

Study Design


Intervention

Other:
Pet AV-45
AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.

Locations

Country Name City State
France Service de neurologie Toulouse

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Toulouse Avid Radiopharmaceuticals, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pet-AV45 cortical binding Method of administration: a bolus IV injection (less than 1 minute of injection time) of 5 MBq / kg with a maximum of 370MBq. The activity corresponding to a 70 kg individual is 350 MBq and corresponds to an effective dose of 12.25mSv (0.035mSv/MBq) Acute phase of intracerebral hemorrhage ie during the first month after hemorrhage onset.
Secondary cerebral microbleeds number and distribution on T2EG MRI sequence Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed Acute phase of intracerebral hemorrhage ie during the first month
Secondary White Matter Lesions Volume on 3D-FLAIR MRI sequence Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed Acute phase of intracerebral hemorrhage ie during the first month
Secondary Cortical thickness and hippocampal volume on 3D-T1 MRI sequence Review safe after checking against usual contraindications (pacemaker, ocular foreign body), painless, lasting about 45 minutes, during which a detailed analysis of the brain will be performed Acute phase of intracerebral hemorrhage ie during the first month
Secondary Neuropsychological performances a neuropsychological examination (tests of memory, language and attention) will be realized. This examination will last approximately 60 minutes and take place in consultation with neurology three months after hemorrhage onset.
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