DECT Ventilation Imaging

NCT02377518 | Terminated

• 1 other identifier: 5601
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Image quality on a qualitative 5 levels scale

  1 day of DECT ventilation imaging

Secondary Outcomes (3)

• Radiation dose

  1 day of DECT ventilation imaging

• Image noise with measurement of signal to noise and contrast to noise ratios

  1 day of DECT ventilation imaging

• Total examination time

  1 day of DECT ventilation imaging

Study Arms (2)

oncologic patients

EXPERIMENTAL

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

lung transplant recipients

EXPERIMENTAL

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

Interventions

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

lung transplant recipients; oncologic patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091 Cedex, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 3, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

FR (1)