- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01382849
F-18-AV-45 Uptake, Spot Sign Presence and Cerebral Amyloid Angiopathy (CAA) in Primary Intracranial Hemorrhage (ICH)
Florbetapir F 18 is an experimental radioactive drug that may allow doctors to image changes in the brain using a PET (Positron Emission Tomography) scanner. The purpose of this study is to evaluate the imaging characteristics of, Florbetapir F 18 (also known as 18F-AV-45) in patients who have previously undergone bleeding in their brains. Florbetapir F 18 binds to amyloid-ß peptide (Aß) that accumulates in the brains of patients with bleeding. These accumulations are called amyloid plaques and when extensive are labeled cerebral amyloid angiopathy (CAA). Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera.
MRI detected microbleeds have been identified as markers of clinically silent hemorrhage from bleeding-prone vessels. Another imaging marker of vessel damage and risk of bleeding is the spot sign (SS). Finally, certain genetic signatures (ApoE genotype) have been shown to be associated with Aß deposition in the brain or predispose patients to higher risks of bleeding. This research study will explore the interactions of these factors and understand the physiology of intracerebral bleeding.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Prior intracranial hemorrhage at least 3 months prior
- Patients >18 years
Exclusion Criteria:
- Modified Rankin score >3.
- Clinically significant medical comorbidities which in the opinion of the investigator might pose a potential safety risk to the subject.
- Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
- Have a history of relevant severe drug allergy or hypersensitivity
- Patients who withdraw consent. Age and gender-matched microbleed patients previously demonstrating MRI microbleeds without prior macrobleeds will be recruited from stroke clinic
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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CAA positive microbleeders
Cerebral amyloid angiopathy (CAA) positive microbleeders
|
probable CAA macrobleeders
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CAA negative microbleeders
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Type of Bleed
Tidsramme: 2-3 weeks
|
Patients will be divided into micro- and macro- bleeders based on MRI detected microhemorhage pattern.
Processing of each patient will take 2-3 weeks.
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2-3 weeks
|
Spot Sign Status
Tidsramme: 2-3 weeks
|
They will be further subdivided by spot sign status into positive or negative.
|
2-3 weeks
|
Amyloid uptake
Tidsramme: 2-3 weeks
|
2-3 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
ApoE genotype
Tidsramme: 2-3 weeks
|
2-3 weeks
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Richard Aviv, Sunnybrook Health Sciences Centre
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjerte-kar-sygdomme
- Karsygdomme
- Metaboliske sygdomme
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Genetiske sygdomme, medfødte
- Proteostase mangler
- Metabolisme, medfødte fejl
- Hjernesygdomme, metaboliske
- Hjernesygdomme, metaboliske, medfødte
- Cerebrale arterielle sygdomme
- Intrakranielle arterielle sygdomme
- Cerebrale småkarsygdomme
- Amyloidose, familiær
- Blødning
- Amyloidose
- Intrakranielle blødninger
- Cerebral amyloid angiopati
- Cerebral amyloid angiopati, familiær
Andre undersøgelses-id-numre
- 18F-AV-45-A14 (Avid Radiopharmaceuticals)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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