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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01382849
First received: June 21, 2011
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

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
Cerebral Amyloid Angiopathy

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Type of Bleed [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
    They will be further subdivided by spot sign status into positive or negative.

  • Amyloid uptake [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ApoE genotype [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
CAA positive microbleeders
Cerebral amyloid angiopathy (CAA) positive microbleeders
probable CAA macrobleeders
CAA negative microbleeders

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382849

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Richard Aviv Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Richard I Aviv, Sunnybrook Hospital
ClinicalTrials.gov Identifier: NCT01382849     History of Changes
Other Study ID Numbers: 18F-AV-45-A14
Study First Received: June 21, 2011
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunnybrook Health Sciences Centre:
amyloid
cerebral amyloid angiopathy
hemorrhages
cerebral spot sign

Additional relevant MeSH terms:
Cerebral Amyloid Angiopathy
Hemorrhage
Intracranial Hemorrhages
Amyloidosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebral Arterial Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Metabolic Diseases
Nervous System Diseases
Pathologic Processes
Proteostasis Deficiencies
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014