- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02120664
Florbetapir Calibration to the Centiloid Scale
January 20, 2017 updated by: Avid Radiopharmaceuticals
A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB
This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Research Site
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Cognitively Normal Subjects
- Males or females ≥ 21 and ≤ 45 years of age
- Mini-mental state examination (MMSE) ≥ 29
Clinically Diagnosed AD Subject
- Males or females ≥ 50 years of age
- Meet clinical criteria for dementia due to probable AD
- MMSE ≥ 16 and ≤ 26
Possible AD Subject
- Males or females ≥ 50 years of age
- Meet clinical criteria for dementia due to possible AD
- MMSE ≥ 16 and ≤ 26
MCI Subject
- Males or females ≥ 60 years of age with cognitive impairment (not dementia)
- MMSE >24 and <29
At Risk Elderly Subject
- Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years of age
- MMSE ≥ 27
Exclusion Criteria:
- Have had or currently have a diagnosis of neurodegenerative disorders other than AD
- Have a current serious or unstable illness that could interfere with completion of the study
- Subject has a known brain lesion, pathology or traumatic brain injury
- Have received or participated in a trial with investigational medications in the past 30 days
- Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Amyloid Negative Subjects
Approximately 10 cognitively normal young subjects will receive a single i.v.
bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie [mCi]) florbetapir (18F) and a single i.v.
bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
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Other Names:
Other Names:
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Experimental: Amyloid Positive Subjects
Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v.
bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v.
bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Florbetapir SUVr Conversion to Centiloid Units
Time Frame: up to 70 minutes post injection
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Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units.
The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively.
A cortical average to cerebellum SUVr was used for this outcome measure.
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up to 70 minutes post injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid
Time Frame: up to 70 minutes post injection
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Correlation coefficient between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units.
The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively.
A cortical average to cerebellum SUVr was used for this outcome measure.
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up to 70 minutes post injection
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Variability of PET Images in Young Healthy Control Subjects.
Time Frame: up to 70 minutes post injection
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Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr.
A cortical average to cerebellum SUVr was used for this outcome measure.
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up to 70 minutes post injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
April 17, 2014
First Submitted That Met QC Criteria
April 21, 2014
First Posted (Estimate)
April 23, 2014
Study Record Updates
Last Update Posted (Actual)
March 9, 2017
Last Update Submitted That Met QC Criteria
January 20, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18F-AV-45-A22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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