The New Combined PET-MR System NextGen PET-MR With Syngo MR XA80A: Evaluation of Diagnostic Image Quality and Usability (Software and Hardware) in the Clinical Setting.

NCT ID: NCT06666387

Last Updated: 2025-04-11

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-07-31

Brief Summary

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This clinical investigation is used to evaluate the novel PET-MR scanner and it is a clinical investigation under MDR.

The focus is on the evaluation of the diagnostic image quality in a clinical setting, considering the speed of the examination and the new functionalities to minimize the patient's lying times. Based on the assessment, the defined protocols and measurement sequences are further improved as necessary to optimize the clinical value of the sequences and user interface components.

Detailed Description

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Conditions

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The Evaluation of a New MD - Combined PET-MR System

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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PET-MR examination

Group Type OTHER

PET-MR examination

Intervention Type DIAGNOSTIC_TEST

PET-MR examination

Interventions

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PET-MR examination

PET-MR examination

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult test subjects for whom a PET-MR examination is indicated and will be performed, or
* Test subjects for whom a PET-CT examination is indicated and will be performed
* Test subjects of legal age who have given their written informed consent to participate in the clinical investigation
* Written consent of the test subject to be informed in the event of suspected clinically relevant incidental findings
* Written consent to the disclosure of a clinically relevant incidental finding to a subsequent physician (release from the duty of confidentiality)
* The test subject´s written consent that the recorded image data may be made available to Siemens Healthcare A/S in pseudonymized form
* Test subjects whose weight does not exceed the permissible weight limit of the patient table (200 kg).

Exclusion Criteria

* Metal in and on the body that causes stress to the test subject during an examination in the FoV of the combined PET-MR system
* All pacemakers and other implants
* Pregnancy: The exclusion of test subjects of childbearing potential is carried out based on a positive pregnancy test
* Test subjects who indicate an increased sensitivity to loud noises
* Test subjects who are incapable of giving consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Healthcare A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Siemens Healthcare A/S

Role: CONTACT

+45 4477 4477

Facility Contacts

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Department of Clinical Physiology and Nuclear Medicine

Role: primary

+45 35 45 35 45

Other Identifiers

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11723119-AVE-V02

Identifier Type: -

Identifier Source: org_study_id

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