Clinical Evaluation Of MP26 Features in Adults

NCT02927327 | Completed Results

• 1 other identifier: 114.03-2016-GES-0001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Imaging; Whole Body Imaging

Outcome Measures

Primary Outcomes (1)

• Diagnostic Image Quality

  scored on a 5-pt Likert scale: 1. Unacceptable 2. Poor 3. Acceptable 4. Good 5. Excellent

  through study completion, an average of 2 months

Secondary Outcomes (3)

• Determination of Diagnostic Acceptability

  through study completion, an average of 2 months

• Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score

  through study completion, an average of 2 months

• Number of Participants Reporting "Yes" On All Binary Performance Scale Questions

  through study completion, an average of 2 months

Other Outcomes (1)

• Summary of Safety Information

  through study completion, an average of 2 months

Study Arms (2)

PET/MR ZTE MRAC

EXPERIMENTAL

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

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

PET/MR Q Static (Q. MRAC)

EXPERIMENTAL

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)

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

Interventions

Zero Echo Time (ZTE) scan for head attenuation DEVICE

The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR. PET/MR ZTE MRAC

PET/MR ZTE MRAC

Q.Static (Q. MRAC) for respiratory motion correction DEVICE

An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images. PET/MR Q Static (Q. MRAC)

PET/MR Q Static (Q. MRAC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Radionuclide Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: John Strohmeyer
• Organization: GE Healthcare

john.strohmeyer@ge.com

609-865-7423

Study Officials

• Tibor Duliskovich, M.D.

  GE Healthcare, Medical Monitor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 7, 2016
• Study Start: November 1, 2016
• Primary Completion: September 20, 2017
• Study Completion: September 20, 2017
• Last Updated: December 6, 2018
• Results First Posted: December 6, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)