Back to resultsStudy to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
[18F]Florbetapir PET imaging
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple Sclerosis
Eligibility Criteria
Eligibility criteria (for all subjects):
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
- Willingness to comply with study procedures
- Willingness to provide written informed consent
- Age greater than or equal to 18 and less than or equal to 60 years old at the time of the informed consent
- Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception until PET testing is completed
- For females, must be of non-childbearing potential or have a negative urine and blood pregnancy test on the day of [18F]Florbetapir PET injection
Inclusion Criteria (Healthy Volunteers):
- No history of or signs of acute or chronic neurological or psychiatric illness based on evaluation by a research physician.
Inclusion Criteria (MS Subjects):
- Have a diagnosis of relapsing remitting MS according to the 2010 MacDonald Criteria
- Have at least 10 demyelinating lesion on brain MRI with the following characteristics:
- Hypointense on T2 weighted images with FLAIR
Exclusion Criteria (for all subjects):
- The subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological (other than RRMS), immunodeficiency, pulmonary, or other disorder or disease.
- Women who are pregnant or actively breastfeeding
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
- The subject has participated in another clinical study within the previous 30 days
- Renal impairment with a creatine clearance <80mL/minute at screening (creatine clearance estimated by Cockcroft-Gault equation)
- The subject is scheduled to have a major surgery or procedure during the time of the study.
Sites / Locations
- Institute for Neurodegenerative Disorders
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]Florbetapir PET imaging
Arm Description
[18F]Florbetapir and PET imaging
Outcomes
Primary Outcome Measures
Total Number of Lesions Detected by [18F]Florbetapir PET
This study demonstrates the feasibility of[18F]Florbetapir PET for identifying demyelinating lesions in relapsing-remitting MS patients. It was expected that lesion size played a factor in identifying white matter lesions with those smaller than 5 mm less evident on PET. Using spherical volumes of interest the extent of reduction in the white matter uptake can be reliably quantified. This requires careful attention to techniques for sampling in both the lesions and white matter control regions for the subject.
Secondary Outcome Measures
Full Information
NCT ID
NCT01767493
First Posted
December 13, 2012
Last Updated
August 26, 2021
Sponsor
Institute for Neurodegenerative Disorders
Collaborators
Biogen
1. Study Identification
Unique Protocol Identification Number
NCT01767493
Brief Title
Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients
Official Title
An Open-label, Non-randomized Study to Evaluate the Feasibility of [18F]Florbetapir Positron Emission Tomography (PET) for Assessment of Demyelination in Patients With Relapsing Remitting Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Neurodegenerative Disorders
Collaborators
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the feasibility of [18F]Florbetapir positron emission tomography (PET) for assessment of demyelination in the patients with relapsing remitting multiple sclerosis.
Detailed Description
The underlying goal of this study is to assess the feasibility of [18F]Florbetapir as an imaging tool to detect demyelination in the brain of MS research participants and compare to similarly aged healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[18F]Florbetapir PET imaging
Arm Type
Experimental
Arm Description
[18F]Florbetapir and PET imaging
Intervention Type
Drug
Intervention Name(s)
[18F]Florbetapir PET imaging
Other Intervention Name(s)
Amyvid
Intervention Description
[18F]Florbetapir and PET imaging
Primary Outcome Measure Information:
Title
Total Number of Lesions Detected by [18F]Florbetapir PET
Description
This study demonstrates the feasibility of[18F]Florbetapir PET for identifying demyelinating lesions in relapsing-remitting MS patients. It was expected that lesion size played a factor in identifying white matter lesions with those smaller than 5 mm less evident on PET. Using spherical volumes of interest the extent of reduction in the white matter uptake can be reliably quantified. This requires careful attention to techniques for sampling in both the lesions and white matter control regions for the subject.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eligibility criteria (for all subjects):
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
Willingness to comply with study procedures
Willingness to provide written informed consent
Age greater than or equal to 18 and less than or equal to 60 years old at the time of the informed consent
Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception until PET testing is completed
For females, must be of non-childbearing potential or have a negative urine and blood pregnancy test on the day of [18F]Florbetapir PET injection
Inclusion Criteria (Healthy Volunteers):
No history of or signs of acute or chronic neurological or psychiatric illness based on evaluation by a research physician.
Inclusion Criteria (MS Subjects):
Have a diagnosis of relapsing remitting MS according to the 2010 MacDonald Criteria
Have at least 10 demyelinating lesion on brain MRI with the following characteristics:
Hypointense on T2 weighted images with FLAIR
Exclusion Criteria (for all subjects):
The subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological (other than RRMS), immunodeficiency, pulmonary, or other disorder or disease.
Women who are pregnant or actively breastfeeding
The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
The subject has participated in another clinical study within the previous 30 days
Renal impairment with a creatine clearance <80mL/minute at screening (creatine clearance estimated by Cockcroft-Gault equation)
The subject is scheduled to have a major surgery or procedure during the time of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danna Jennings, MD
Organizational Affiliation
Institute for Neurodegenerative Disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.indd.org
Description
Institute for Neurodegenerative Disorders
Learn more about this trial
Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients
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