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

NCT01382849 | Withdrawn

• 1 other identifier: 18F-AV-45-A14
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Amyloid Angiopathy

Keywords

amyloid; cerebral amyloid angiopathy; hemorrhages; cerebral spot sign

Outcome Measures

Primary Outcomes (3)

• Type of Bleed

  Patients will be divided into micro- and macro- bleeders based on MRI detected microhemorhage pattern. Processing of each patient will take 2-3 weeks.

  2-3 weeks

• Spot Sign Status

  They will be further subdivided by spot sign status into positive or negative.

  2-3 weeks

• Amyloid uptake

  2-3 weeks

Secondary Outcomes (1)

• ApoE genotype

  2-3 weeks

Study Arms (3)

CAA positive microbleeders

Cerebral amyloid angiopathy (CAA) positive microbleeders

probable CAA macrobleeders

CAA negative microbleeders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Macrobleed patients will be selected from a prospectively maintained ICH database at Sunnybrook Hospital.

You may qualify if:

• Prior intracranial hemorrhage at least 3 months prior
• Patients \>18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy; Alzheimer Disease; Hemorrhage

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Aviv

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 27, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

CA (1)