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

• Sponsor: Institute for Neurodegenerative Disorders (Other)
• Overall Status: Completed
• CT.gov ID: NCT01767493
• Collaborator: Biogen (Industry)
• Enrollment: 19
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: [18F]Florbetapir PET imaging	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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 Start Date: Nov 1, 2012
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [18F]Florbetapir PET imaging [18F]Florbetapir and PET imaging	Drug: [18F]Florbetapir PET imaging; [18F]Florbetapir and PET imaging; Other Names: Amyvid

Outcome Measures

Primary Outcome Measures

1. Total Number of Lesions Detected by [18F]Florbetapir PET [1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Neurodegenerative Disorders	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Institute for Neurodegenerative Disorders
• Biogen

Investigators

• Principal Investigator: Danna Jennings, MD, Institute for Neurodegenerative Disorders

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Institute for Neurodegenerative Disorders

Publications

None provided.

• Responsible Party: Institute for Neurodegenerative Disorders
• ClinicalTrials.gov Identifier: NCT01767493
• Other Study ID Numbers: Florbetapir MS 01
• First Posted: Jan 14, 2013
• Last Update Posted: Aug 30, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by Institute for Neurodegenerative Disorders: Multiple Sclerosis
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

Participant Flow

Arm/Group Title	[18F]Florbetapir Imaging
Arm/Group Description	[18F]Florbetapir and PET imaging
Period Title: Overall Study
STARTED	19
COMPLETED	16
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	[18F]Florbetapir PET Imaging
Arm/Group Description	[18F]Florbetapir and PET imaging
Overall Participants	19
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	12 63.2%
Male	7 36.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	[18F]Florbetapir PET Imaging
Arm/Group Description	[18F]Florbetapir and PET imaging
Measure Participants	19
Number [Lesions]	194

Adverse Events

Time Frame	Adverse event data was collected for 1 year.
Adverse Event Reporting Description	There were three adverse events and all three were considered to be unrelated to the imaging or other study procedures.
Arm/Group Title	[18F]Florbetapir PET Imaging
Arm/Group Description	[18F]Florbetapir and PET imaging
All Cause Mortality
	[18F]Florbetapir PET Imaging
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Serious Adverse Events
	[18F]Florbetapir PET Imaging
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	[18F]Florbetapir PET Imaging
	Affected / at Risk (%)	# Events
Total	2/19 (10.5%)
Gastrointestinal disorders
Gastroesophageal Reflux	1/19 (5.3%)	1
Injury, poisoning and procedural complications
Wrist Pain	1/19 (5.3%)	1
Respiratory, thoracic and mediastinal disorders
Chest Wall Congestion	1/19 (5.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.