Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767493
• Other study ID #: Florbetapir MS 01
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2021
• Source: Institute for Neurodegenerative Disorders
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• [18F]Florbetapir PET imaging
[18F]Florbetapir and PET imaging

Locations

Country	Name	City	State
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Neurodegenerative Disorders	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year

External Links

•   Institute for Neurodegenerative Disorders