Clinical Evaluation Of MP26 Features in Adults

General Electric (GE)

Status: Completed

Conditions: Whole Body Imaging; Brain Imaging

Treatments: Device: Zero Echo Time (ZTE) scan for head attenuation; Device: Q.Static (Q. MRAC) for respiratory motion correction

Study type: Interventional

Funder types: Industry

Identifiers

NCT02927327

114.03-2016-GES-0001

Details and patient eligibility

About

The purpose of the study is to collect representative clinical images (head and whole-body scans) of demonstrated diagnostic quality using the next-generation SIGNA PET/MR device equipped with investigational software components in adult population. The images and summary data from this study are intended for use in regulatory submission.

Full description

Primary Objective: To demonstrate diagnostic image quality of image sets with ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR in representative clinical cases of the general imaging population.

Secondary Objective(s): To verify diagnostic acceptability, ease of use, and functionality of ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR at clinical sites.

Safety Objective(s): To collect information about safety events and device issues.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Are adults (aged 18 or older);
2. Have preexisting clinical indication for PET/CT or PET/MR with radiotracer injection (for subjects that will undergo ZTE procedures, a preexisting clinical indication for PET/CT is required);
3. Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection;
4. Can hear without assistive devices and have necessary mental capacity to follow study instructions;
5. Are willing and able to provide written informed consent;
6. Are considered eligible for MRI and PET exams, according to site institutional safety policies.

Exclusion criteria

1. Were previously enrolled in the study;
2. If female, are pregnant or of undetermined pregnancy status;
3. Cannot fit safely in the device (>55 cm axial diameter or >227 kgs body weight);
4. Have implants or attached medical devices that could be unsafe for MRI;
5. Have medical conditions or require urgent care that could make it unsafe to participate

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

PET/MR ZTE MRAC

Experimental group

Description:

PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment. Zero Echo Time (ZTE) scan for head attenuation

Treatment:

Device: Zero Echo Time (ZTE) scan for head attenuation

PET/MR Q Static (Q. MRAC)

Experimental group

Description:

Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment. PET/MR Q Static (Q. MRAC)

Treatment:

Device: Q.Static (Q. MRAC) for respiratory motion correction