Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate whether an entire-body positron emission tomography (PET) scanner can be exploited to improve evaluation, monitoring and measurement of both peripheral and central demyelination in multiple sclerosis (MS) patients.
To collect exploratory data using the most recent PET-CT scanners with their increased detection sensitivity and spatial resolution for the evaluation of F18-florbetapir radiopharmaceutical uptake in the nervous system of the entire body with special attention to correlation of radiotracer activity levels in the myelinated, demyelinated, or remyelinated white matter of multiple sclerosis (MS) patients compared to normal healthy subjects. The pilot study will be conducted on 20 participants as a clinical research trial of PET amyloid and myelin imaging with the primary objective of identifying possible differences in F18-florbetapir radiotracer activity for MS patients compared to normal healthy subjects, and the secondary objective of monitoring psychological health of those participants who elect to be informed of imaging results and who complete a panel of psychometric scales before and after imaging results disclosure.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Siemens Biograph Vision PET-CT scans | Other | Parallel study arms defined by PET-CT scanners by different manufacturer and model |
|
| United Imaging uEXPLORER PET-CT scans | Other | Parallel study arms defined by PET-CT scanners by different manufacturer and model |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entire-body PET-CT scans | Diagnostic Test | Entire-body PET-CT scans will be performed with state-of-the-art scanners with different manufacturers' models including Siemens Biograph Vision, United Imaging uEXPLORER and possibly other recently FDA-approved PET-CT scanners. |
| Measure | Description | Time Frame |
|---|---|---|
| Entire-body PET imaging of demyelination of peripheral and central nervous system | Exploratory analysis of relative regional increases and/or decreases of Amyvid activity | During 1 day single PET-CT scan |
| Psychometric questionnaire for monitoring psychological health | Assessments of participants | Up to 90 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carl Taswell, MD, PhD | Contact | 949-481-3121 | ctaswell@brainhealthalliance.org |
| Name | Affiliation | Role |
|---|---|---|
| Carl Taswell, MD, PhD | Brain Health Alliance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Health Alliance | Recruiting | Ladera Ranch | California | 92694 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26251415 | Background | Taswell C, Villemagne VL, Yates P, Shimada H, Leyton CE, Ballard KJ, Piguet O, Burrell JR, Hodges JR, Rowe CC. 18F-FDG PET Improves Diagnosis in Patients with Focal-Onset Dementias. J Nucl Med. 2015 Oct;56(10):1547-53. doi: 10.2967/jnumed.115.161067. Epub 2015 Aug 6. |
| Label | URL |
|---|---|
| Research Protocol for Exploratory Study of Entire-body PET Scans for Multiple Sclerosis (EPSMS) | View source |
Not provided
All information and data will be shared with investigators at collaborating imaging sites prior to publication of the results, and with all other investigators after publication of the results.
Anonymized de-identified data will be available after completion of the study.
Anonymized de-identified data will be available to registered users of the data.
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Different PET-CT scanners (make and model) determine the different study arms for the intervention defined as a PET-CT medical imaging scan with the Amyvid imaging agent.
Not provided
Not provided
Participants will be de-identified; results will be anonymized.
Not provided
| Amyvid radiopharmaceutical | Drug | Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants |
|
| Amended Protocol for Exploratory Study of Entire-body PET Scans for Multiple Sclerosis (EPSMS) | View source |
| EPSMS Clinical Trial | View source |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |