MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation... | NCT03562806

Studies
MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging

NCT03562806

Sponsor

University of Zurich

Status

Terminated

Last Update Posted

May 23, 2022Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Lung Diseases

Interventions

PET/MR image acquisition

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

May 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Tested MR sequence was inferior in preliminary evaluation

Expanded Access Info

Start Date

May 23, 2018Actual

Primary Completion Date

Mar 9, 2021Actual

Completion Date

Mar 9, 2021Actual

First Submitted Date

May 23, 2018

First Submission Date that Met QC Criteria

Jun 7, 2018

First Posted Date

Jun 20, 2018Actual

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

May 16, 2022

Last Update Posted Date

May 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

MRI 3D UTE Hyper-Cones & ZTE for PET/MR lung attenuation correction & for lung diagnostic imaging

Detailed Description

The primary objective is to clinically test the feasibility of 3D UTE Hyper-Cones & ZTE in capturing lung density of patients with lung diseases at reasonable clinical imaging times compared to standard MR lung protocols (LAVA-Flex, PROPELLER). Secondly, we want to investigate if Hyper-Cones & ZTE can be used for lung imaging such as vessels and air-pathways, oncological patients, lung nodules and lung infiltration & parenchyma pathophysiology such as chronic obstructive pulmonary disease.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PET/MR (single arm)	Experimental	PET and MR sequence acquisition on SIGNA PET/MR device	Diagnostic Test: PET/MR image acquisition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/MR image acquisition	Diagnostic Test	Acquisition of PET and MR sequences on SIGNA PET/MR device.	PET/MR (single arm)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning.	Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed consent and signature
clinical PET/CT planned and performed at Wagi site in Schlieren
male or female patients
from 18 to 80 years of age.

Exclusion Criteria:

- same exclusion criteria as for the clinical PET/CT exam (i.e. pregnant women).

Additional exclusion criteria:

- standard exclusion criteria for clinical MRI (evaluated by clinical standard determined by MRI questionnaire).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Huellner, M.D.	University Hospital, Zürich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Department of Nuclear Medicine		Zurich		8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided