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Morphofunctional Lung Analysis by PET and CT After Lung Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746914
First Posted: December 11, 2012
Last Update Posted: March 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
  Purpose

72 hours after lung transplantation, patients undergo a positron emission tomography (PET) scan and a computed tomography (CT) scan in order to analyse lung function and morphology.

Aim of the study is to analyse complications onset (in particular primary graft dysfunction), and evaluate 90 days mortality after lung transplantation.


Condition
Disorder Related to Lung Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morphofunctional Lung Analysis by Positron Emission Tomography and Computed Tomography After Lung Transplantation

Resource links provided by NLM:


Further study details as provided by Davide Chiumello, Policlinico Hospital:

Primary Outcome Measures:
  • Number of patients alive [ Time Frame: up to 90 days from transplantation ]

Secondary Outcome Measures:
  • incidence of complications other than primary graft dysfunction [ Time Frame: 72 hours and 90 days ]
  • incidence of primary graft dysfunction [ Time Frame: 72 hours and 90 days after transplantation ]

Enrollment: 30
Study Start Date: January 2013
Study Completion Date: January 2016
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lung transplantated patients
Patients undergone lung transplantation

Detailed Description:

Pulmonary transplantation is considered as a lifesaving procedure in end-stage pulmonary disease. However morbidity and mortality after lung transplantation are still significant.

Primary graft dysfunction (PGD) is the main cause of early death. PGD is similar to acute lung injury (ALI)/ acute respiratory distress syndrome (ARDS): oxygenation is compromised, pulmonary compliance is decreased, chest Rx shows several infiltrates, and alveolar damage is present.

25% of patients develops PGD within 72 hours from transplantation and 30 days mortality is eight times higher in patients who develop PGD.

72 hours after lung transplantation, patients, whose clinical condition allow to bring them to nuclear medicine department, will undergo pulmonary computed tomography (CT) to study lung morphology and measure lung recruitability and positron emission tomography (PET) to study lung functionality and estimate lung inflammation.

Aim of this study is to investigate the onset of PGD and other complications and to determine 72 hours and 90 days mortality after lung transplantation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lung Transplantated patients
Criteria

Inclusion Criteria:

  • lung transplantation
  • ≥ 18 years

Exclusion Criteria:

  • < 18 years
  • patient' s clinical conditions not allowing patient transport from ICU to Nuclear Medicine Unit
  Contacts and Locations
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): NCT01746914


Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Milan, Italy, 20122
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Davide Chiumello, MD Policlinico Hospital
Principal Investigator: Franco Valenza, MD Policlinico Hospital
  More Information

Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT01746914     History of Changes
Other Study ID Numbers: 201212
First Submitted: December 7, 2012
First Posted: December 11, 2012
Last Update Posted: March 30, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided