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

Cerebral Amyloid Angiopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01382849
• Other study ID #: 18F-AV-45-A14
• Status: Withdrawn
• Phase: N/A
• First received: June 21, 2011
• Last updated: November 17, 2014
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Amyloid Angiopathy
• Hemorrhage
• Intracranial Hemorrhages

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Spot Sign Status	They will be further subdivided by spot sign status into positive or negative.	2-3 weeks	No
Primary	Amyloid uptake		2-3 weeks	No
Secondary	ApoE genotype		2-3 weeks	No