Actively Recruiting

Early Phase 1
Age: 40Years - 85Years
All Genders
ID06932809

Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 18F-JSS20-183A

Led by University of Pennsylvania · Updated on 2025-12-23

90

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers aim to study the distribution, metabolism, excretion, and brain uptake of a new radiotracer called 18F-JSS20-183A. This tracer is designed to measure a protein called 4Repeat Tau (4Rtau) that abnormally accumulates in the brains of people with tauopathies, a group of neurodegenerative diseases including Progressive Supranuclear Palsy, Corticobasal Syndrome, genetic Frontotemporal Lobar Degeneration, Parkinson's disease, Alzheimer's disease, as well as in healthy individuals. This multicenter study is funded by an NIH grant and involves multiple leading universities collaborating to better understand these diseases. Participants will receive an injection of 18F-JSS20-183A followed by a dynamic PET/CT scan lasting up to two hours to observe the tracer's behavior in the body and brain. Some may also undergo a brain MRI and additional amyloid PET scans or blood tests to explore the tracer's specificity. Blood samples and urine collections may be taken for analysis during or after the scan. The study plans to enroll up to 90 adults aged 40 to 85 years, including patients with various tauopathies and healthy controls. During the study, participants will complete imaging sessions and neurological assessments including video interviews. Researchers will monitor how the tracer distributes in organs and the brain and assess any adverse events for safety. The study includes detailed evaluations such as PET scan quality, brain tracer uptake, blood metabolite analysis, and dosimetry calculations. Participation may last around four weeks for outcome measurements and safety monitoring, with some participants possibly undergoing follow-up scans or tests.

CONDITIONS

Brief Title

Study of Biodistribution, Metabolism, Excretion and Brain Uptake 18F-JSS20-183A

Who Can Participate

Age: 40Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40 to 85 years
  • Male or female participants
  • Willingness to provide written informed consent
  • Ability to participate according to institutional and federal guidelines
  • Clinical diagnosis confirmed by consensus committee or established criteria for tauopathies or healthy controls
  • Presence of a study partner if unable to provide informed consent
  • Agreement to brain donation is encouraged but not required
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding females
  • Parkinsonism forms other than Progressive Supranuclear Palsy-Richardson Syndrome and Parkinson disease
  • History of significant or ongoing alcohol or substance abuse
  • Inability to tolerate imaging, arterial line or IV placement, or blood draw procedures
  • Contraindications to MRI such as non-compatible implanted medical devices
  • Any current medical condition considered by a physician to compromise safety or study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo imaging and laboratory procedures including a 2-hour PET scan with the 18F-JSS20-183A radiotracer, and may also have a brain MRI and an amyloid PET scan along with neurological assessments to evaluate brain uptake and metabolism of the tracer.

1 to 2 visits depending on imaging procedures

Long-term Monitoring

Duration - 4 weeks

Participants are monitored for safety and any adverse events for up to 4 weeks following imaging procedures.

Approximately 1 follow-up visit within 4 weeks

Trial Site Locations

Total: 2 locations

1

University of California

San Francisco, California, United States, 94143

Actively Recruiting

2

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Frequently Asked Questions

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