Diagnostic Comparison of PET-magnetic Resonance and PET-C... | NCT02316431

Studies
Diagnostic Comparison of PET-magnetic Resonance and PET-CT in Patients With Oncologic Diseases

NCT02316431

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Dec 16, 2016Estimated

Enrollment

142Actual

Phase

Not provided

Conditions

Neoplasm Staging

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Dec 9, 2014

First Submission Date that Met QC Criteria

Dec 11, 2014

First Posted Date

Dec 12, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2016

Last Update Posted Date

Dec 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios will be evaluated to create imaging protocols which are time efficient and diagnostically accurate.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with correct TNM staging defined with PET/magnetic resonance versus PET/CT		12 month

Secondary Outcomes

Measure	Description	Time Frame
Number of minutes needed per PET/magnetic resonance protocol compared to PET/CT		12 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients from 18-90 years
Written informed consent
Patients with a proven or suspected oncological disease referred for a clinically -Indicated PET/CT with of without contrast media

Exclusion Criteria:

Pregnant or breast feeding women
Non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia)
Inclusion in another clinical trial 30 days prior to inclusion
Age < 30years
Contraindication for MRI (cardiac pacemaker, certain metal implants, claustrophobia
Known allergies to contrast CT or MRI contrast media
Patients with an glomerular filtration rate of < 60ml/min/1.73m2

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with a proven or suspected oncological disease referred for a clinically indicated PET/CT with of without contrast media.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Veit-Haibach, MD	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Diagnostic and Interventional Radiology		Zurich	Canton of Zurich	8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28914600	Derived	Sekine T, Delso G, Zeimpekis KG, de Galiza Barbosa F, Ter Voert EEGW, Huellner M, Veit-Haibach P. Reduction of 18F-FDG Dose in Clinical PET/MR Imaging by Using Silicon Photomultiplier Detectors. Radiology. 2018 Jan;286(1):249-259. doi: 10.1148/radiol.2017162305. Epub 2017 Sep 14.