Clinical trial NCT02927327: Clinical Evaluation Of MP26 Features in Adults
Official title: Clinical Evaluation Of MP26 Features in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Imaging
Whole Body Imaging
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2016-10-07
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Image Quality
timeFrame: through study completion, an average of 2 months
Secondary outcomes:
measure: Determination of Diagnostic Acceptability
timeFrame: through study completion, an average of 2 months
measure: Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score
timeFrame: through study completion, an average of 2 months
measure: Number of Participants Reporting "Yes" On All Binary Performance Scale Questions
timeFrame: through study completion, an average of 2 months
Other outcomes:
measure: Summary of Safety Information
timeFrame: through study completion, an average of 2 months
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: GE Healthcare, Medical Monitor
name: Tibor Duliskovich, M.D.
role: STUDY_DIRECTOR
References: