N/A
Completed N=62
Clinical Evaluation of an Integrated PET/MRI System
Subjects With Clinical Indication for PET/CT
Source: ClinicalTrials.gov NCT02071706 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Number Usable PET/MRI Image Sets — 70 Usable image sets
Summary
The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Usable PET/MRI Image Sets |
70 | — |
| PRIMARY Number of Diagnostic Quality Images |
67 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have a clinical indication for a PET/CT exam
- Subject must be at least eighteen (18) years of age; and
- 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
- Subject must be able to hear and understand instructions without assistive devices; and
- Subject must provide written informed consent; and
- Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and
- Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and
- 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
- Subjects who have any axial diameter larger than 55 cm; or
- Subjects with a weight greater than 227 kgs; or
- 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
- Subjects that have implants with MR Unsafe labeling; or
- 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
- Subjects who have a contraindication to MRI according to the screening policy of the participating site
Data sourced from ClinicalTrials.gov (NCT02071706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.