Entire-body PET Scans for Multiple Sclerosis (EPSMS)

Brain Health Alliance

Status and phase: Enrolling; Early Phase 1

Conditions: Multiple Sclerosis

Treatments: Diagnostic Test: Entire-body PET-CT scans; Drug: Amyvid radiopharmaceutical

Study type: Interventional

Funder types: Other

Identifiers

NCT04390009

BHA-2020-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Siemens Biograph Vision PET-CT scans

Other group

Description:

Parallel study arms defined by PET-CT scanners by different manufacturer and model

Treatment:

Drug: Amyvid radiopharmaceutical

Diagnostic Test: Entire-body PET-CT scans

United Imaging uEXPLORER PET-CT scans

Other group

Description:

Parallel study arms defined by PET-CT scanners by different manufacturer and model

Treatment:

Drug: Amyvid radiopharmaceutical

Diagnostic Test: Entire-body PET-CT scans