RECRUITING

CW2IP2: Imaging and Diagnostic Assessments

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Conditions

TauopathiesAmyloid PETMovement disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-07-20
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06083467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants: Patients in all cohorts will range from 40 to 85 yrs and will be both male and female.
  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. Participants who are deemed unable to provide informed consent must have a designated Legally Authorized Representative(LAR) present for consent and a Study Partner to accompany them to study visits. The LAR and the Study Partner may be the same person.
  3. * Clinical diagnoses for each cohort will be determined by consensus committee for diagnostic agreement (PD, MSA, PSP, FTD or Healthy control)
  1. * Females who are pregnant or breast feeding at the time of screening will be excluded
  2. * Forms of parkinsonism other than PD, PSP and MSA as defined above
  3. * Major psychiatric disorder (e.g. schizophrenia or bipolar disorder)
  4. * History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
  5. * Contraindications or Inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician
  6. * Implanted medical device or other contraindication to MRI
  7. * 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
  8. * Refusal to consent to brain donation (except for HC cohort). All non-HC participants must agree to postmortem brain donation..

Contacts and Locations

Study Contact

Erin o Schubert
CONTACT
2155736569
erin.schubert@pennmedicine.upenn.edu
Refatun Momo
CONTACT
215-573-6693
refatun.momo@pennmedicine.upenn.edu

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-20
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2023-07-20
Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

  • Amyloid PET
  • Movement disorders

Additional Relevant MeSH Terms

  • Tauopathies