Trial Outcomes & Findings for Study to Evaluate the Feasibility of [18F]Florbetapir PET for Assessment in MS Patients (NCT NCT01767493)

NCT ID: NCT01767493

Last Updated: 2021-08-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 19 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2021-08-30

Participant Flow

Participant milestones

Measure	[18F]Florbetapir Imaging \[18F\]Florbetapir and PET imaging
Overall Study STARTED	19
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	[18F]Florbetapir Imaging \[18F\]Florbetapir and PET imaging
Overall Study screen failures	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	[18F]Florbetapir PET Imaging n=19 Participants \[18F\]Florbetapir and PET imaging
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	[18F]Florbetapir PET Imaging n=19 Participants \[18F\]Florbetapir and PET imaging
Total Number of Lesions Detected by [18F]Florbetapir PET	194 Lesions

Adverse Events

[18F]Florbetapir PET Imaging

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	[18F]Florbetapir PET Imaging n=19 participants at risk \[18F\]Florbetapir and PET imaging
Injury, poisoning and procedural complications Wrist Pain	5.3% 1/19 • Number of events 1 • Adverse event data was collected for 1 year. There were three adverse events and all three were considered to be unrelated to the imaging or other study procedures.
Respiratory, thoracic and mediastinal disorders Chest Wall Congestion	5.3% 1/19 • Number of events 1 • Adverse event data was collected for 1 year. There were three adverse events and all three were considered to be unrelated to the imaging or other study procedures.
Gastrointestinal disorders Gastroesophageal Reflux	5.3% 1/19 • Number of events 1 • Adverse event data was collected for 1 year. There were three adverse events and all three were considered to be unrelated to the imaging or other study procedures.

Additional Information

Stephanie Pizarro

Invicro

Phone: 203-990-1613

Email: spizarro@invicro.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place