CW2IP2: Imaging and Diagnostic Assessments

Tauopathies Clinical Trial

Official title: Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Imaging and Diagnostic Assessments

Status Recruiting

Clinical Trial Summary

This current protocol will provide the key data to help determine the specificity of our to-be-developed radiotracers by implementing a multi-site diagnostic assessment core and PET imaging of A-beta amyloid (may be completed at some sites as part of another protocol) that is commonly deposited in the brains of people with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP) or Frontotemporal Dementia (FTD) as well as healthy controls. This multicenter U19 grant is centered at U Pennsylvania (U Penn) (PI: Robert Mach) in collaboration with U Pittsburgh (Pitt), Yale University, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). U Penn will act as the single IRB of Record (sIRB) for this multi-center project and subjects will be recruited from all sites.

Clinical Trial Description

This current protocol will provide the key data to help determine the specificity of our to-be-developed radiotracers by implementing a multi-site diagnostic assessment core and PET imaging of A-beta amyloid (may be completed at some sites as part of another protocol) that is commonly deposited in the brains of people with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP) or Frontotemporal Dementia (FTD) as well as healthy controls. This multicenter U19 grant is centered at U Pennsylvania (U Penn) (PI: Robert Mach) in collaboration with U Pittsburgh (Pitt), Yale University, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). U Penn will act as the single IRB of Record (sIRB) for this multi-center project and subjects will be recruited from all sites. Sites will have local Radiation Research Safety Committee or Radioactive Drug Research Committee oversight over radiation safety related issues specific to the A-beta amyloid radiotracer used at that site (Florbetaben (18F) or 11C-PiB), if the site chooses to include A-beta amyloid PET imaging. Some sites may participate in this diagnostic assessment study without the PET/CT imaging if that data is collected as part of other studies conducted at the site.

The investigators will recruit up to 10 people with PD, 10 healthy controls, 10 with MSA, 10 with PSP and 14 with FTD (4 of these FTD participants are expected tau-negative FTD controls and 10 are expected tau-positive).

Key components of the multi-site diagnostic core will provide the infrastructure for these human imaging studies including regulatory activities (with a sIRB, at Penn); consistency of diagnostic criteria and clinical evaluations (with clinical consensus diagnosis of all participants); common calibration of PET scanners; model consents and protocols; and collection and distribution of clinical and imaging data.

At the sites participating in A-beta amyloid PET/CT as part of this protocol, imaging will be used to evaluate A-beta amyloid deposition in the brain using well established PET A-beta amyloid radiotracers. Each subject will have one positron emission tomography (PET) or PET/computed tomography (PET/CT) scan session. Subjects with a historical positive amyloid PET scan or a negative amyloid PET scan within 2 years may not be required to undergo another scan. Prior scans will be reviewed by an investigator.

Participants who are undergoing A-beta amyloid scan will undergo either approximately 20-30 minutes of static scanning or a 60 minute dynamic scan of the brain depending on the radiotracer selected at the clinical site. The standard uptake time after injection and the dose will vary depending upon which amyloid radiotracer is selected at each site.

Subjects will be required to have a brain MRI performed within 12 months of study enrollment. If the subject has not had a brain MRI that is deemed acceptable for use for this study by an investigator, they will be asked to undergo a research brain MRI after they have consented for this study. ;

Related Conditions & MeSH terms

• Tauopathies

• NCT number: NCT06083467
• Study type: Interventional
• Source: University of Pennsylvania
• Contact: Erin o Schubert
• Phone: 2155736569
• Email: erin.schubert@pennmedicine.upenn.edu
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 20, 2023
• Completion date: July 31, 2028