Clinical Evaluation of an Integrated PET/MRI System

Subjects With Clinical Indication for PET/CT Clinical Trial

— PET/MR_ZURICH  

Official title:

Clinical Evaluation of an Integrated PET/MRI System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071706
• Other study ID #: 114-2013-GES-0010
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: January 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject must have a clinical indication for a PET/CT exam

2. Subject must be at least eighteen (18) years of age; and

3. Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging; and

4. Subject must be able to hear and understand instructions without assistive devices; and

5. Subject must provide written informed consent; and

6. Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and

7. Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and

8. Subject must be able to participate in a PET/MR imaging session within 2 hours of concluding their PET/CT exam and within 4 hours of PET radiotracer administration.

Exclusion Criteria:

1. Subjects who have any axial diameter larger than 55 cm; or

2. Subjects with a weight greater than 227 kgs; or

3. Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator; or

4. Subjects that have implants with MR Unsafe labeling; or

5. Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol ; or

6. Subjects who have a contraindication to MRI according to the screening policy of the participating site

Related Conditions & MeSH terms

• Subjects With Clinical Indication for PET/CT

Intervention

Device:
• PET/MRI system
Enrolled subject undergoes PET/MR scan

Locations

Country	Name	City	State
Switzerland	UniversitätsSpital Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Usable PET/MRI Image Sets	The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale	1 day
Primary	Number of Diagnostic Quality Images	Number of images sets deemed diagnostic quality by the investigator	1 day