Normal Ventilatory and Perfusion Pulmonary Function in TEMP (3DSPECSTAT)

April 1, 2020 updated by: University Hospital, Brest

Normal Ventilatory and Perfusion Pulmonary Function in TEMP: Generation of 3D Statistical Maps From Normal Examinations

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • Médecine nucléaire - Hôpital Morvan (CHRU de Brest)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posterior to Anterior and Inferior to Superior uptake relative difference on parametric mean registered SPECT map versus non registered SPECT
Time Frame: through study completion, an average of 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Study Director: Pierre Yves Le Roux, MD, Phd, CHRU Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2019

Primary Completion (Actual)

October 15, 2019

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 2, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 29BRC19.0129

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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