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Morphofunctional Lung Analysis by PET and CT After Lung Transplantation

This study has been completed.
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital Identifier:
First received: December 7, 2012
Last updated: March 29, 2016
Last verified: March 2016

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.

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)
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.


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

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
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Please refer to this study by its identifier: NCT01746914

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

Responsible Party: Davide Chiumello, MD, Policlinico Hospital Identifier: NCT01746914     History of Changes
Other Study ID Numbers: 201212
Study First Received: December 7, 2012
Last Updated: March 29, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided processed this record on August 23, 2017