Normal Ventilatory and Perfusion Pulmonary Function in TEMP | NCT04332406

Studies
Normal Ventilatory and Perfusion Pulmonary Function in TEMP

NCT04332406

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Apr 2, 2020Actual

Enrollment

96Actual

Phase

Not provided

Conditions

Patents With Normal VQ/SPECT

Interventions

Not provided

Countries

France

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 2020

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 13, 2019Actual

Primary Completion Date

Oct 15, 2019Actual

Completion Date

Oct 15, 2019Actual

First Submitted Date

Sep 26, 2019

First Submission Date that Met QC Criteria

Apr 1, 2020

First Posted Date

Apr 2, 2020Actual

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 1, 2020

Last Update Posted Date

Apr 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Ventilation - perfusion SPECT is attractive for lung function assessement. Unfortunately, it is very difficult to delineate normal to abnormal areas because of physiological uptake heterogeneity.

In that context, it would be of interest to build statistical maps from registrered normal studies and propose a new methodology for normal SPECT delineation

Detailed Description

Patients with normal VQ SPECT-CT will be analysed. After a image proccesing workflow including rigid registration, non rigid registration and normalization, a voxelized mean and standard deviation map will be created. Those maps will be analyzed in regards of physiology and litterature.

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

96Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Posterior to Anterior and Inferior to Superior uptake relative difference on parametric mean registered SPECT map versus non registered SPECT	parametric mean and standard deviation maps are build from elastic registration of normal lung V/Q SPECT-CT. A ROI based quantitative regional uptake comparison is performed to verify the influence of elastic registration on radiotracer distribution	through study completion, an average of 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

normal perfusion and ventilation scans, and no parenchyma or pleural abnormality on low dose CT
confirmation by a second senior physician

Exclusion Criteria:

Patients with history of pulmonary disease:

chronic obstruction pulmonary disease,
previous pulmonary embolism,
surgery of the lungs
radiotherapy of the lungs

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

Patients referred to the department of nuclear medicine of Brest University Hospital, France, for suspected acute pulmonary embolism

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Yves Le Roux, MD, Phd	CHRU BREST	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Médecine nucléaire - Hôpital Morvan (CHRU de Brest)		Brest		29609	France