F-18-AV-45 Uptake, Spot Sign Presence and Cerebral Amyloid Angiopathy (CAA) in Primary Intracranial Hemorrhage (ICH)

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01382849

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Amyloid Angiopathy

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

F-18-AV-45 Uptake, Spot Sign Presence and Cerebral Amyloid Angiopathy (CAA) in Primary Intracranial Hemorrhage (ICH)

Study Start Date :

Aug 1, 2011

Anticipated Primary Completion Date :

Aug 1, 2012

Anticipated Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
CAA positive microbleeders Cerebral amyloid angiopathy (CAA) positive microbleeders
probable CAA macrobleeders
CAA negative microbleeders

Outcome Measures

Primary Outcome Measures

Type of Bleed [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.
Spot Sign Status [2-3 weeks]
They will be further subdivided by spot sign status into positive or negative.
Amyloid uptake [2-3 weeks]

Secondary Outcome Measures

ApoE genotype [2-3 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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