Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector

Pilot Study Intended to Provide Input for Future Designs Using the PET Alpha Ring Detector and to Support the Pre-market Notification of a Future Product

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01731860

Enrollment

Registered

2012-11-22

Start date

2012-11-30

Completion date

Unknown

Last updated

2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus of Study is Imaging Performance With the New Technology Compared With the Currently Available Technology.

Keywords

PET/CT, Philips

Brief summary

A standard PET/CT scanner is comprised of two different machines: An X-ray computed tomography scanner (CT), which gives information about your anatomy, and a Positron Emission Tomography scanner (PET) that provides information about how the body functions. Both of these work together to make the final images for doctors to review. As part of this research study the investigators would like to test a new scanner technology by evaluating the quality of the images obtained using this new PET system. The scanner the investigators would use is able to do both types of examination, the standard PET/CT and the additional research PET. The new PET system adds a second scanner ring to the standard PET/CT. This allows the patient to stay on the same imaging table for both studies. Being in this study does not change how the standard PET/CT will be done.

Interventions

DEVICEAdditional PET Scan

Additional PET Scan with no additional radiopharmaceutical administration.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients are at least 18 years * Patients are medically stable * Patients scheduled for clinically necessary PET/CT examination

Exclusion criteria

* Patients who are pregnant * Patients who are unwilling/unable to sign the Informed Consent Form * Patients who are cognitively impaired and unable to provide informed consent * Patients who have experienced adverse events to PET/CT examinations

Design outcomes

Primary

Measure	Time frame	Description
Imaging Capabilities and Performance of the Alpha Ring	Within 1 month of image acquisition	Images acquired using the investigational device will be compared with the images obtained using the approved clinical device. The qualitative image review will be performed by the reading radiologist/nuclear medicine physician.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026