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RecruitingEarly Phase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans, Injections, Blood draws, MRI scans, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: 1. Patients in all cohorts will be male or female adults from 40 to 85 years of age. 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. 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: 1. 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 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

Study sites (2)

CA

PA