Entire-body PET Scans for Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Participants will be de-identified; results will be anonymized.

Study Groups

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Siemens Biograph Vision PET-CT scans

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

Group Type OTHER

Entire-body PET-CT scans

Intervention Type 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.

Amyvid radiopharmaceutical

Intervention Type DRUG

Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants

United Imaging uEXPLORER PET-CT scans

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

Group Type OTHER

Entire-body PET-CT scans

Intervention Type 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.

Amyvid radiopharmaceutical

Intervention Type DRUG

Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants

Interventions

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Entire-body PET-CT scans

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.

Intervention Type DIAGNOSTIC_TEST

Amyvid radiopharmaceutical

Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes