Clinical Evaluation Of MP26 Features in Adults

Completed · Not applicable

Conditions studied: Brain Imaging, Whole Body Imaging

In brief

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.

Key facts

Study ID

NCT02927327

Run by

GE Healthcare

People needed

61

Starts

2016-11-01

Expected to finish

2017-09-20

Last updated by the study team

2018-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are adults (aged 18 or older);
• 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);
• Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection;
• Can hear without assistive devices and have necessary mental capacity to follow study instructions;
• Are willing and able to provide written informed consent;
• Are considered eligible for MRI and PET exams, according to site institutional safety policies.

You may not qualify if…

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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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