Clinical trial NCT04390009: Entire-body PET Scans for Multiple Sclerosis
Official title: Exploratory Study of Entire-body PET Scans for Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Entire-body PET imaging
Lead sponsor: Brain Health Alliance
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Multiple sclerosis (MS) patients diagnosed by a credentialed neurologist experienced with care of multiple sclerosis patients.
* Normal healthy subjects.
* Willing and able to lie motionless on the PET-CT scanner bed for at least 10 minutes and up to 20 minutes for the duration of the PET-CT medical imaging scan.

Exclusion Criteria:

* Any additional complicating medical illness other than MS including any other neuropsychiatric illness unrelated to MS diagnosed prior to the onset of initial symptoms of MS.
* Pregnancy or breast feeding.
* Diabetes or other metabolic-endocrine disorders.
* Any known concomitant acute infection.
* History of metastatic or locally invasive cancer.
* Recent surgery, chemotherapy or radiation therapy.

Primary outcomes:
measure: Entire-body PET imaging of demyelination of peripheral and central nervous system
timeFrame: During 1 day single PET-CT scan
measure: Psychometric questionnaire for monitoring psychological health
timeFrame: Up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ladera Ranch
country: United States
facility: Brain Health Alliance
state: California
Study officials:
affiliation: Brain Health Alliance
name: Carl Taswell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.