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DECT Ventilation Imaging

Primary Purpose

For Oncologic Patients, Potentially Operable Lung Tumor, With a Recent (Less Than 1 Month) VQ Scan

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for For Oncologic Patients

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Radiologie B - Nouvel Hôpital Civil - CHRU de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

oncologic patients

lung transplant recipients

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Image quality on a qualitative 5 levels scale

Secondary Outcome Measures

Radiation dose
Image noise with measurement of signal to noise and contrast to noise ratios
Total examination time

Full Information

First Posted
February 25, 2015
Last Updated
March 21, 2018
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02377518
Brief Title
DECT Ventilation Imaging
Official Title
Quantitative Ventilation Imaging With Dual Energy Computed Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Change of device used for dual energy computed tomography with Xenon
Study Start Date
June 2015 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
For Oncologic Patients, Potentially Operable Lung Tumor, With a Recent (Less Than 1 Month) VQ Scan, For Lung Transplant Recipients, Single of Bilateral Lung Transplant, From 5 Months Onwards, With Recent (Less Than 1 Month) Respiratory Functional Explorations

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oncologic patients
Arm Type
Experimental
Arm Description
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
Arm Title
lung transplant recipients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media
Primary Outcome Measure Information:
Title
Image quality on a qualitative 5 levels scale
Time Frame
1 day of DECT ventilation imaging
Secondary Outcome Measure Information:
Title
Radiation dose
Time Frame
1 day of DECT ventilation imaging
Title
Image noise with measurement of signal to noise and contrast to noise ratios
Time Frame
1 day of DECT ventilation imaging
Title
Total examination time
Time Frame
1 day of DECT ventilation imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Radiologie B - Nouvel Hôpital Civil - CHRU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091 Cedex
Country
France

12. IPD Sharing Statement

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DECT Ventilation Imaging

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