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

Withdrawn

• Conditions: Cerebral Amyloid Angiopathy

• Registration Number: NCT01382849
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Study Start: 2011-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

1. Modified Rankin score >3.
2. Clinically significant medical comorbidities which in the opinion of the investigator might pose a potential safety risk to the subject.
3. Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
4. Have a history of relevant severe drug allergy or hypersensitivity
5. Patients who withdraw consent. Age and gender-matched microbleed patients previously demonstrating MRI microbleeds without prior macrobleeds will be recruited from stroke clinic

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amyloid uptake	2-3 weeks
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.

Secondary Outcome Measures

Name	Time	Method
ApoE genotype	2-3 weeks

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada