Demonstration Of A Next Generation PET CT System

NCT ID: NCT05122715

Last Updated: 2022-05-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-09

Study Completion Date

2022-09-01

Brief Summary

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The intent of this evaluation is to obtain user feedback on device performance, user preference, image quality, workflow, and new device features, a necessary part of product development. This study will also help to inform protocol development in reducing both scan time and/or radiologic tracer dose. The goal of this study is to collect a library of image data from the hybrid PET/CT system to be used for evaluation and optimization of the image quality of the system in a clinical setting and as comparison with the standard of care hybrid PET/CT system, Discovery MI 25m (DMI5R).

Detailed Description

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Conditions

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Oncology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OMNI PET/CT scan first

Group Type OTHER

Additional PET/CT Scan

Intervention Type DEVICE

The subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner.

DMI PET/CT scan first

Group Type OTHER

Additional PET/CT Scan

Intervention Type DEVICE

The subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner.

Interventions

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Additional PET/CT Scan

The subject will undergo two PET/CT scans, one on the DMI scanner and one on the OMNI scanner.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult, who is at least 18 years of age;
2. A clinical indication for PET/CT examination according to current clinical practice standards;
3. Able and willing to provide informed consent for participation in this study

Exclusion Criteria

1. Diabetic patient with a glucose level ≥ 150 mg/dl at the time of the exam (for FDG) or,
2. Known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age. No study specific pregnancy test will be performed for this study); or,
3. Previously enrolled in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian W Thomsen

Role: STUDY_DIRECTOR

GE Healthcare

Locations

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Rambam Healthcare Campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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215514655

Identifier Type: -

Identifier Source: org_study_id

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