ClinicalTrials.gov record NCT06932809

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhaseEarly phase 1A very early study, usually in a small number of people, to learn how the body handles a treatment. It is not designed to show whether the treatment works.
Age40 years old to 85 years old
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This early-phase diagnostic imaging study evaluates a new PET tracer, 18F-JSS20-183A, to measure how it distributes in the body and whether it enters and binds in the brain. It enrolls people with tauopathies (for example PSP, CBS, genetic FTLD), people with Parkinson disease or Alzheimer's disease, and healthy volunteers. Participants receive an injection of the tracer and undergo a dynamic brain PET scan (about up to 120 minutes); some may also have a brain MRI, blood draws (possible arterial line), urine collection, and an amyloid PET scan.

What it is studying. The study is testing how 18F-JSS20-183A behaves in humans: its whole-body biodistribution, metabolism and excretion, and whether the tracer shows measurable and selective brain uptake in people with 4‑repeat tauopathies compared with non-tau neurodegenerative disease and healthy controls. The study will also calculate human radiation dosimetry from whole-body scans and record safety information.

What the researchers hope to learn. Measure biodistribution, metabolism, and excretion of 18F-JSS20-183A and calculate human dosimetry. Collect pilot data on brain uptake and whether the tracer selectively binds in 4R tauopathies versus other groups. Record safety and adverse event information for the tracer.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 18F-JSS20-183A. The goal of this radiotracer is to quantify 4Repeat Tau (4Rtau) protein that is abnormally deposited in the brain of people with a class of neurodegenerative diseases called tauopathies, such as Progressive Supranuclear Palsy (PSP), Corticobasal Syndrome (CBS), syndromes of genetic Frontotemporal Lobar Degeneration (genetic FTLD) as well as participants with Parkinson disease (PD), Alzheimer's Disease (AD) and healthy controls. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt), Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WUSTL). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • 18F-JSS20-183A PET
Diagnostic test
  • Brain MRI
  • Amyloid PET
Behavioral
  • Neurological Assessments

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Patients in all cohorts will be male or female adults from 40 to 85 years of age.
  • 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.
  • Diagnosis-specific inclusion criteria: Clinical diagnoses will be determined by consensus committee (except AD and HC cohorts) for diagnostic agreement using video exams of each participant that are stored at WashU in a secured video repository with view-only access exclusively by secured virtual private network (VPN) connection. Video exam and screening assessments for PSP, CBS, MSA, PD, and FTLD may not be required to be repeated if they have been done within 6 months of enrollment, unless requested at the discretion of an investigator to document changes in clinical progression. A consensus committee will not be required to be repeated for participants who have already had a consensus committee diagnosis documented.

Exclusion criteria

  • Females who are pregnant or breast feeding will be excluded, a urine pregnancy test will be performed in women of child-bearing potential prior to injection of 18F-JSS20-183A 11C-PiB or 18F-Florbetaben
  • Forms of parkinsonism other than PSP-RS, and PD as defined above
  • History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
  • Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician
  • Contraindication to MRI, such as non-compatible implanted medical device
  • 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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 18F-JSS20-183A. The goal of this radiotracer is to quantify 4Repeat Tau (4Rtau) protein that is abnormally deposited in the brain of people with a class of neurodegenerative diseases called tauopathies, such as Progressive Supranuclear Palsy (PSP), Corticobasal Syndrome (CBS), syndromes of genetic Frontotemporal Lobar Degeneration (genetic FTLD) as well as participants with Parkinson disease (PD), Alzheimer's Disease (AD) and healthy controls. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt), Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WUSTL). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites. 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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive an injection of the investigational PET tracer 18F-JSS20-183A and undergo a dynamic PET brain scan lasting up to about 120 minutes (some sites may scan brain and body). A second IV or an arterial line may be placed for blood samples and radioactivity counts during the scan; blood draws can be omitted at the investigator's discretion and some participants at Penn may provide a urine sample. Participants may also have a research brain MRI (same or separate day), neurological assessments including a recorded video exam, and some may be asked to have an amyloid PET or a blood test for pTau. Safety is monitored and adverse events will be collected.

How the study is structured. Interventional, single-group, non-masked, early-phase diagnostic imaging study. Each participant receives one injection of 18F-JSS20-183A and undergoes dynamic PET imaging of the brain (and whole body at some sites). Some participants may also have a research brain MRI, amyloid PET, blood sampling (venous or optional arterial line), and urine collection. There is no randomization or placebo group.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
May 9, 2025
Primary completion
April 2030 (estimated)
Study completion
April 2030 (estimated)
Target enrollment
90 participants (estimated)
Last updated on registry
Dec 23, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Pennsylvania

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
screening assessments
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
PET/CT
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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