DECT Ventilation Imaging

For Lung Transplant Recipients Clinical Trial

Official title:

Quantitative Ventilation Imaging With Dual Energy Computed Tomography

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02377518
• Other study ID #: 5601
• Status: Terminated
• Phase: N/A
• First received: February 25, 2015
• Last updated: March 21, 2018
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2018
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• For Lung Transplant Recipients
• For Oncologic Patients
• From 5 Months Onwards
• Potentially Operable Lung Tumor
• Single of Bilateral Lung Transplant
• With a Recent (Less Than 1 Month) VQ Scan
• With Recent (Less Than 1 Month) Respiratory Functional Explorations

Intervention

Radiation:
• Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media

Locations

Country	Name	City	State
France	Service de Radiologie B - Nouvel Hôpital Civil - CHRU de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality on a qualitative 5 levels scale		1 day of DECT ventilation imaging
Secondary	Radiation dose		1 day of DECT ventilation imaging
Secondary	Image noise with measurement of signal to noise and contrast to noise ratios		1 day of DECT ventilation imaging
Secondary	Total examination time		1 day of DECT ventilation imaging