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

NCT ID: NCT01731860

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients receiving PET/CT

Patients already scheduled for a clinically necessary PET/CT scan.

Group Type EXPERIMENTAL

Additional PET Scan

Intervention Type DEVICE

Additional PET Scan with no additional radiopharmaceutical administration.

Interventions

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Additional PET Scan

Additional PET Scan with no additional radiopharmaceutical administration.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

Imarc Research, Inc.

INDUSTRY

Sponsor Role collaborator

Philips Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter F Faulhaber, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospital Case Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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Alpha Ring 12-001

Identifier Type: -

Identifier Source: org_study_id

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