A Phase 4 interventional study of [18F]Florbetapir PET imaging in Multiple Sclerosis, sponsored by Institute for Neurodegenerative Disorders. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-30.
Sponsored by Institute for Neurodegenerative Disorders · Phase 4, Interventional, and Other
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Institute for Neurodegenerative Disorders is the lead sponsor of 40 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligibility criteria (for all subjects):
Inclusion Criteria (Healthy Volunteers):
Inclusion Criteria (MS Subjects):
Exclusion Criteria (for all subjects):
\[18F\]Florbetapir and PET imaging
Drug: [18F]Florbetapir PET imaging
\[18F\]Florbetapir and PET imaging
Also known as: Amyvid
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.
Time frame: 1 year
| Milestone | [18F]Florbetapir Imaging |
|---|---|
| Started | 19 |
| Completed | 16 |
| Not completed | 3 |
| Withdrew: Screen failures | 3 |
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.
| Lesions | [18F]Florbetapir PET Imaging |
|---|---|
| Total Number of Lesions Detected by [18F]Florbetapir PET | 194 |
Collected over Adverse event data was collected for 1 year.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| [18F]Florbetapir PET Imaging | 0/19 (0%) | 0/19 (0%) | 2/19 (10.5%) |
| Event | [18F]Florbetapir PET Imaging |
|---|---|
| Wrist PainInjury, poisoning and procedural complications | 1/19 |
| Chest Wall CongestionRespiratory, thoracic and mediastinal disorders | 1/19 |
| Gastroesophageal RefluxGastrointestinal disorders | 1/19 |
| Age, Categorical(Participants) | [18F]Florbetapir PET Imaging |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | [18F]Florbetapir PET Imaging |
|---|---|
| Female | 12 |
| Male | 7 |
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Institute for Neurodegenerative Disorders