Respiratory Motion Correction of Cardiac Combined Positro... | NCT03200132

Studies
Respiratory Motion Correction of Cardiac Combined Positron Emission Tomography and Magnetic Resonance Imaging (PET/MRI)

NCT03200132

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Apr 8, 2022Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Cardiac Imaging

Interventions

Cardiac PET/MRI

Countries

Netherlands

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

Apr 2022

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

Jun 26, 2017Actual

Primary Completion Date

Oct 14, 2021Actual

Completion Date

Oct 14, 2021Actual

First Submitted Date

Jun 26, 2017

First Submission Date that Met QC Criteria

Jun 26, 2017

First Posted Date

Jun 27, 2017Actual

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

Apr 7, 2022

Last Update Posted Date

Apr 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study evaluates the possibility of Magnetic Resonance Imaging (MRI) based respiratory motion correction of simultaneously acquired cardiac Positron Emission Tomography (PET) images.

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

15Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac PET/MRI	Diagnostic Test	For patients undergoing 18-Fluor- fluorodeoxyglucose (18F-FDG) PET/MRI or PET/Computed Tomography (CT), additional cardiac PET/MRI scans are acquired.

Measure	Description	Time Frame
Target-to-background ratio (TBR)		15-20 minutes

Measure	Description	Time Frame
Signal-to-noise ratio (SNR)		15-20 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18F-FDG injection for clinical diagnostic PET/MRI or PET/CT

Exclusion Criteria:

Diet-suppressed myocardial uptake of 18F-FDG
General exclusion criteria for MRI (i.e. metallic implants, claustrophobia, pregnancy, etc.)
Not willing to be informed about incidental findings

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients receiving 18F-FDG for clinical diagnostic PET/MRI or PET/CT.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim Wildberger, MD PhD	Maastricht University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Hospital		Maastricht	Limburg	6229HX	Netherlands