PennPET Explorer Scanner Evaluation

NCT04617912 | Active Not Recruiting FDA Device

• 1 other identifier: 843546
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

Positron Emission Tomography (PET) is a procedure that uses a special type of machine to take pictures of the inside of the body after a radioactive drug is administered. The radioactive drug that is used for this study may be an FDA approved imaging drug or may be used as an investigational imaging drug as part of another study for which participants are taking part. PET using various radiotracers is useful for the diagnosis of various diseases, including cancer, brain diseases, infection, and heart or lung disease. The purpose of this study is to test a research PET machine called the PennPET Explorer long-axial field-of-view scanner. This research PET machine can image a larger section of the body than the current clinical PET scanners, allowing most of the body to be imaged at one time. This scanner is still an investigational device and is being tested in this study to collect more information about how best to use this type of whole body scanner.

Conditions

Healthy; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Image Performance of the LAFOV PennPET Explorer

  Noise behavior, structural detail and local contrast will be combined to report overall image quality using a numerical scale (1 = poor image quality, 5 = superior image quality).

  Through study completion, an average of 1 year.

Study Arms (1)

PennPET Explorer

EXPERIMENTAL

All subjects will be scanned in the CT scanner and then the scanner bed will be moved into position in the PennPET Explorer for initiation of the PET scan. For all PET scans a radioactive imaging drug is used. The radiotracer injection may be performed according to one of the following scenarios: 1. As part of a clinical standard-of-care (SOC) PET/CT or PET/MRI scan (using an FDA-approved radiotracer; the PennPET Explorer cannot yet accommodate a study that requires a commercially available 510(k)-approved instrument for clinical results, subjects in this group will be scanned on both a commercial instrument (PET/CT or PET.MRI) and the PennPET Explorer), 2. As part of another research study (using either an FDA-approved radiotracer or an investigational radiotracer), 3. As a research injection designed specifically to utilize the PennPET Explorer (using an FDA-approved radiotracer).

Device: Long AFOV PennPET Explorer

Interventions

Long AFOV PennPET Explorer DEVICE

A long-axial field-of-view (LAFOV) time-of-flight PET scanner, developed at the University of Pennsylvania, being tested for real-world applications.

PennPET Explorer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants, at least 18 years of age
• Participants or study partner must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. Subjects who are unable to provide consent must have a legally authorized representative or designated "study partner" who can provide consent on their behalf.

You may not qualify if:

• Inability to tolerate imaging procedure in the opinion of an investigator.
• Serious or unstable medical or psychological conditions or lack of mobility that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: November 5, 2020
• Study Start: November 12, 2020
• Primary Completion: January 22, 2026
• Study Completion (Estimated): January 22, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)