Study of Biodistribution, Metabolism, Excretion and Brain Uptake 18F-JSS20-183A
NCT ID: NCT06932809
Last Updated: 2025-12-23
Study Results
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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RECRUITING
EARLY_PHASE1
90 participants
INTERVENTIONAL
2025-05-09
2030-04-30
Brief Summary
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Detailed Description
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Participating clinical sites will recruit up to 90 subjects total; up to 20 people with PSP, 10 with CBS, 15 with genetic FTLD, 10 with AD, 10 with PD and 25 healthy controls across sites with all participants ranging from 40-85 years old. We will encourage equal participation of males and females.
This protocol will include up to 90 evaluable participants across all centers (Penn, Yale, UCSF, WUSTL, Pitt), the whole-body biodistribution analysis will be done at Penn. Investigators anticipate enrollment of up to 15-20 participants at each clinical site, who will undergo up to 120-minutes of dynamic PET/CT scan over the brain, or brain and body if scanned on a long axial-field-of-view scanner, starting approximately at the same time as the injection of radiotracer. A second IV or an arterial line may be placed, preferably in the arm contralateral to the side of injection, for blood metabolite analysis and/or radioactive counts at various times during the scanning session. These blood sample collections can be omitted at the discretion of the investigator. For participants at Penn that may be part of BioD analysis, urine may be collected at the end of the scan session. Participants may also undergo a research brain MRI that may be on the same or a separate day from the PET.
PET imaging sessions will include an injection of ≤ 8 mCi (approximate range for most studies is anticipated to be 3-8 mCi at sites with a standard PET scanner or a lower dose may be used at sites with a high sensitivity scanner) of 18F-JSS20-183A. Biodistribution, metabolism, excretion and pilot brain uptake data will be collected and human dosimetry will be calculated from participants scanned at Penn who have whole body scans. PET scans will be collected to evaluate image quality and collect preliminary information on brain uptake of 18F-JSS20-183A in the disease cohorts and healthy controls. The safety of 18F-JSS20-183A will also be evaluated in all participants. Some participants (usually those with positive 18F-JSS20-183A PET scan) may also be asked to have an amyloid-beta (Aβ) PET scan or a blood draw to measure pTau to investigate specificity of 18F-JSS20-183A.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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18F-JSS20-183A PET
Participants will undergo 18F-JSS20-183A PET scan, they may also have a brain MRI and Amyloid PET scan as well as neurological assessments.
18F-JSS20-183A PET
2 hour Positron Emission Tomography (PET) scan using new radiotracer 18F-JSS20-183A.
Brain MRI
MRI scan of the brain.
Amyloid PET
PET scan with Florbetaben F18 or 11C-PiB.
Neurological Assessments
Neurological assessments, including a video interview.
Interventions
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18F-JSS20-183A PET
2 hour Positron Emission Tomography (PET) scan using new radiotracer 18F-JSS20-183A.
Brain MRI
MRI scan of the brain.
Amyloid PET
PET scan with Florbetaben F18 or 11C-PiB.
Neurological Assessments
Neurological assessments, including a video interview.
Eligibility Criteria
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Inclusion Criteria
2. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures or Participants who are deemed unable to provide informed consent must have a designated study partner present for consent and to accompany them to study visits.
Investigators will ask disease cohort participants to agree to brain donation, but this choice is not mandatory for participation in this study.
Exclusion Criteria
2. Forms of parkinsonism other than PSP-RS, and PD as defined above
3. History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
4. Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician
5. Contraindication to MRI, such as non-compatible implanted medical device
6. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study
40 Years
85 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Locations
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University of California
San Francisco, California, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Facility Contacts
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Karen Smith
Role: primary
Carol Soppe
Role: backup
Erin Schubert
Role: primary
Ilya Nasrallah, MD, PhD
Role: backup
Other Identifiers
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857138
Identifier Type: -
Identifier Source: org_study_id