Application of Amyloid PET in Cerebral Amyloid Angiopathy (CAA)
Primary Purpose
Cerebral Amyloid Angiopathy, Intracranial Hemorrhages, Alzheimer Disease
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
amyloid PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebral Amyloid Angiopathy focused on measuring Stroke, intracerebral hemorrhage, amyoid PET, cerebral amyloid angiopathy
Eligibility Criteria
Inclusion Criteria:
- Age:above 20 years old with ICH or AD, or control subjects.
- Patient agrees to participate in the study and receive cerebral amyloid PET and MRI SWI and perfusion studies.
Exclusion Criteria:
- Patients could not receive the PET and MRI studies, including but not limited to poor cooperative agitation impeding adequate study, allergy to contrast medium, hemodynamic instability, implantation of cardiac pacemaker, past history of receiving aneurysm clipping, panic mood to MRI study.
- Patients with pregnancy or recently having a plan for pregnancy.
- Patient or family who does not agree to participate in the study.
Sites / Locations
- National Taiwan Univeristy Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
amyloid PET
Arm Description
PET/CT
Outcomes
Primary Outcome Measures
PET imaging
PET data will reconstruct with ordered set expectation maximization, corrected for attenuation, and each frame will be evaluated to verify adequate count statistics and absence of head motion.
Secondary Outcome Measures
Full Information
NCT ID
NCT03542656
First Posted
May 20, 2018
Last Updated
May 29, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03542656
Brief Title
Application of Amyloid PET in Cerebral Amyloid Angiopathy
Acronym
CAA
Official Title
Application of Amyloid PET in Cerebral Amyloid Angiopathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2014 (Actual)
Primary Completion Date
February 17, 2016 (Actual)
Study Completion Date
March 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this project, we will try to enhance the diagnostic potentials of amyloid PET in CAA by combination of dynamic amyloid PET with MRI SWI and MR perfusion images. We will also try to investigate the roles of CAA in patients with drug-related ICH and validate the accuracy of clinical CAA diagnostic criteria. In addition, we will try to study the characteristics of long-term progression of amyloid deposition in CAA patients. This project will enroll 100 patients with ICH, 30 patients with AD, and 30 control subjects. Each patient will receive the above image studies, followed by data analysis and comparison.
Detailed Description
Intracranial hemorrhage (ICH) consists of about a quarter of stroke subtype. For elderly, cerebral amyloid angiopathy (CAA) is a common etiology of ICH. In patients with CAA, abnormal beta amyloid protein diffusely deposits at cerebral vasculatures, which disrupts the normal vessel structure and increases the risk of bleeding. The standard diagnosis for CAA requires pathological evidences of amyloid deposition at cerebral arteries. Clinically, a diagnosis of CAA-related ICH is usually only made in an elderly developing cortical or subcortical lobar ICH without undergoing biopsy. Brain images using the SWI sequence of MRI study may show several lobar microbleeds in patients with CAA. However, there is still no direct and precise non-invasive diagnostic tool for CAA until now.
Amyloid PET, using 11C-PiB to image amyloid burden, has been used for detecting the cerebral amyloid protein deposition in patients with Alzheimer's dementia (AD) for years. Recently, amyloid PET has also been applied in diagnosis of CAA. CAA patients showed diffusely increased global PiB retention as compared to control subjects and the distribution of PiB retention is also different from that seen in patients with AD in general. Nevertheless, the applications of amyloid PET in CAA diagnosis are still not well established and many important issues still need to be extensively addressed. For example, amyloid PET sometimes is not able to exactly distinguish CAA patients from control and AD subjects. The roles of CAA in patients with drug-related ICH are still unclear. The accuracy of CAA diagnosis using clinical criteria still needs further validation. In addition, the characteristics for long-term progression of amyloid deposition are still unknown in CAA patients.
In this project, we will try to enhance the diagnostic potentials of amyloid PET in CAA by combination of dynamic amyloid PET with MRI SWI and MR perfusion images. We will also try to investigate the roles of CAA in patients with drug-related ICH and validate the accuracy of clinical CAA diagnostic criteria. In addition, we will try to study the characteristics of long-term progression of amyloid deposition in CAA patients. This project will enroll 100 patients with ICH, 30 patients with AD, and 30 control subjects. Each patient will receive the above image studies, followed by data analysis and comparison.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Amyloid Angiopathy, Intracranial Hemorrhages, Alzheimer Disease
Keywords
Stroke, intracerebral hemorrhage, amyoid PET, cerebral amyloid angiopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amyloid PET
Arm Type
Experimental
Arm Description
PET/CT
Intervention Type
Drug
Intervention Name(s)
amyloid PET
Intervention Description
Dynamic PET acquisition for 60 minutes will be acquired after injection of 10 mCi 11C-PiB (39 frames: 8 x 15 seconds, 4 x 60 seconds, 27 x120 seconds).
Primary Outcome Measure Information:
Title
PET imaging
Description
PET data will reconstruct with ordered set expectation maximization, corrected for attenuation, and each frame will be evaluated to verify adequate count statistics and absence of head motion.
Time Frame
in 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age:above 20 years old with ICH or AD, or control subjects.
Patient agrees to participate in the study and receive cerebral amyloid PET and MRI SWI and perfusion studies.
Exclusion Criteria:
Patients could not receive the PET and MRI studies, including but not limited to poor cooperative agitation impeding adequate study, allergy to contrast medium, hemodynamic instability, implantation of cardiac pacemaker, past history of receiving aneurysm clipping, panic mood to MRI study.
Patients with pregnancy or recently having a plan for pregnancy.
Patient or family who does not agree to participate in the study.
Facility Information:
Facility Name
National Taiwan Univeristy Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Application of Amyloid PET in Cerebral Amyloid Angiopathy
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