Trial Outcomes & Findings for Clinical Evaluation of an Integrated PET/MRI System (NCT NCT02071706)

Results Overview

The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

1 day

Results posted on

2019-04-08

Participant Flow

First participant enrolled on January 20, 2014. Last participant enrolled on July 07, 2014 at the Zurich University Hospital site. Subject or participant recruitment was prematurely terminated because the sponsor had determined that sufficient data was collected for regulatory submissions

Subjects/participants were enrolled in one of three study segments and received a clinically indicated PET/CT exam with radiopharmaceutical injection followed by PET/MRI scanning. Up to two subject datasets (each dataset labelled with unique subject ID) can be collected from one enrolled participant/subject.

Participant milestones

Participant milestones
Measure	Single-Arm PET/MRI Single-group evaluation of PET/MRI for diagnostic quality of image PET/MRI system: Enrolled subject undergoes PET/MR scan
Overall Study STARTED	62
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Single-Arm PET/MRI Single-group evaluation of PET/MRI for diagnostic quality of image PET/MRI system: Enrolled subject undergoes PET/MR scan
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Clinical Evaluation of an Integrated PET/MRI System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-Arm PET/MRI n=62 Participants Single-group evaluation of PET/MRI for diagnostic quality of image PET/MRI system: Enrolled subject undergoes PET/MR scan
Age, Customized Equal to or more than 18 years of age	62 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale

Outcome measures

Outcome measures
Measure	Single-Arm PET/MRI n=62 Participants Single-group evaluation of PET/MRI for diagnostic quality of image PET/MRI system: Enrolled subject undergoes PET/MR scan
Number Usable PET/MRI Image Sets	70 Usable image sets

PRIMARY outcome

Timeframe: 1 day

Population: PET/MR Scans with qualitative comments

Number of images sets deemed diagnostic quality by the investigator

Outcome measures

Outcome measures
Measure	Single-Arm PET/MRI n=74 Number of Image Sets Single-group evaluation of PET/MRI for diagnostic quality of image PET/MRI system: Enrolled subject undergoes PET/MR scan
Number of Diagnostic Quality Images	67 Image sets

Adverse Events

Single-Arm PET/MRI

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single-Arm PET/MRI n=62 participants at risk Single-group evaluation of PET/MRI for diagnostic quality of image PET/MRI system: Enrolled subject undergoes PET/MR scan
Musculoskeletal and connective tissue disorders Warming	3.2% 2/62 • approximately 7 months subject participants were considered to be actively enrolled from the time the subject entered the scan room for their PET/MR procedure to the time the subject left the PET/MR scan room. AE monitoring were conducted starting from the subject participants signing off the informed consent form until the subject participant left the PET/MR scan room

Additional Information

Yvonne Celestial

GE Healthcare

Phone: +33625023857

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60