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This study involves a Positron Emission Tomography (PET) scan using a new investigational radioactive tracer, [18F]-FZTA, to detect inflammation in the brain. The tracer will be tested in healthy younger adults and individuals with Multiple Sclerosis.
The primary objective of this initial IND study is to evaluate the safety of [18F]-FZTA for PET imaging of S1P1 expression. The study will begin with whole-body PET dosimetry in healthy adult volunteers to determine the safety and safe radiation dose for a single PET scan in humans. Following this, brain and neck imaging will be conducted in both healthy adult control participants and individuals with multiple sclerosis (both male and female) to characterize [18F]-FZTA uptake in the brain. An analysis of the radiolabeled metabolite will also be completed as part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy participants | Healthy participants will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer [18F]-FZTA. Participants will then undergo [18F]-FZTA PET scan. |
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| Participants with Multiple Sclerosis | Participants with Multiple Sclerosis will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer [18F]-FZTA. Participants will then undergo a brain [18F]-FZTA PET scan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F] FZTA | Drug | Participants will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer [18F]-FZTA. A PET-certified medical professional will prepare and administer the [18F]-FZTA. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 7+20% mCi of [18F]-FZTA followed by a 10 mL 0.9% sodium chloride (normal saline) flush. |
| Measure | Description | Time Frame |
|---|---|---|
| PET imaging studies of [18F]-FZTA in healthy control participants and participants with Multiple Sclerosis, and measuring the uptake of [18F]-FZTA tracer. | To test the hypothesis that specific binding of [18F]-FZTA is elevated in participants with Multiple Sclerosis compared to healthy normal control participants. | Through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Aim 1: Dosimetry/Safety group will consist of 10 healthy adult normal volunteers (5 males and 5 females) who will be recruited and undergo whole-body PET/CT imaging to assess the safety, dosimetry, and metabolism of [F-18]FZTA. All 10 participants will also undergo a short MRI without contrast.
Aim 2: Proof of Concept/Healthy Cohort will consist of 15 healthy adult volunteers (Males and Females).
Aim 3: Proof of Concept/MS cohort consists of 10 MS patients who are on stable therapy.
Aim 4: Proof of Concept/MS cohort consists of newly diagnosed 20 RRMS patients who will be started on high-efficacy drugs.
Aims 2,3, and 4 will undergo [F-18]FZTA PET imaging of the brain and neck, brain MRI, and an optional [C-11]CS1P1 and [F-18]FDG PET imaging.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jayashree Rajamanickam | Contact | 314-273-6140 | jayashree.r@wustl.edu | |
| Kelley Jackson | Contact | 314 362 3613 | kelleyj@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tammie Benzinger, MD., PhD. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | Recruiting | St Louis | Missouri | 63110 | United States |
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Whole blood for future research
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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