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OpenTrials
Completed

NCT Number: NCT01731860

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Case Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Additional PET Scan

Device

Additional PET Scan with no additional radiopharmaceutical administration.

Primary outcomes

  1. Imaging Capabilities and Performance of the Alpha Ring

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Philips Healthcare

Industry

Collaborators

  • Case Western Reserve University
  • Imarc Research, Inc.
  • University Hospitals Cleveland Medical Center

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
First posted
Nov 22, 2012
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.