DECT Ventilation Imaging

March 21, 2018 updated by: University Hospital, Strasbourg, France

Quantitative Ventilation Imaging With Dual Energy Computed Tomography

Demonstrate the feasibility of dual energy computed tomography using Krypton as a gaseous contrast media in order to study the in vivo ventilation.

Two different clinical situations will be tested :

  • Prediction of postoperative pulmonary function for oncologic patients
  • Detection of Bronchiolitis Obliterans in lung transplant recipients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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
      • Strasbourg, France, 67091 Cedex
        • Service de Radiologie B - Nouvel Hôpital Civil - CHRU de Strasbourg

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

For oncologic patients :

  • Potentially operable lung tumor
  • With a recent (less than 1 month) V/Q scan

For lung transplant recipients :

  • Single of bilateral lung transplant
  • From 5 months onwards
  • With recent (less than 1 month) respiratory functional explorations

Exclusion criteria:

  • Impossibility to follow simple orders or control one's respiration
  • Known Krypton hypersensitivity
  • History of malignant hyperthermia
  • Increased intracranial pressure
  • Minors
  • Pregnant Women

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oncologic patients

Prediction of postoperative pulmonary function.

Patients with an operable lung cancer: dual energy computed tomography with Krypton will be tested to estimate the postoperative FEV1
Radiation: Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media
Experimental: lung transplant recipients

Detection of BOS

6 months+ lung transplant recipients will be tested using dual energy computed tomography with Krypton, with acquisition in the end-inspiratory and end-expiratory phase, in search of regional air trapping.
Radiation: Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Image quality on a qualitative 5 levels scale
Time Frame: 1 day of DECT ventilation imaging
1 day of DECT ventilation imaging

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiation dose
Time Frame: 1 day of DECT ventilation imaging
1 day of DECT ventilation imaging
Image noise with measurement of signal to noise and contrast to noise ratios
Time Frame: 1 day of DECT ventilation imaging
1 day of DECT ventilation imaging
Total examination time
Time Frame: 1 day of DECT ventilation imaging
1 day of DECT ventilation imaging

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5601

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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