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Trial record 2 of 2 for:    Lung Cancer | energy | France

DECT Ventilation Imaging

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ClinicalTrials.gov Identifier: NCT02377518
Recruitment Status : Terminated (Change of device used for dual energy computed tomography with Xenon)
First Posted : March 3, 2015
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease Intervention/treatment Phase
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 Radiation: Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative Ventilation Imaging With Dual Energy Computed Tomography
Actual Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Image quality on a qualitative 5 levels scale [ Time Frame: 1 day of DECT ventilation imaging ]

Secondary Outcome Measures :
  1. Radiation dose [ Time Frame: 1 day of DECT ventilation imaging ]
  2. Image noise with measurement of signal to noise and contrast to noise ratios [ Time Frame: 1 day of DECT ventilation imaging ]
  3. Total examination time [ Time Frame: 1 day of DECT ventilation imaging ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377518


Locations
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France
Service de Radiologie B - Nouvel Hôpital Civil - CHRU de Strasbourg
Strasbourg, France, 67091 Cedex
Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02377518     History of Changes
Other Study ID Numbers: 5601
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases