Morphofunctional Lung Analysis by PET and CT After Lung Transplantation

Morphofunctional Lung Analysis by Positron Emission Tomography and Computed Tomography After Lung Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Disorder Related to 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Milano, Milan, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Lung Transplantated patients

Description

Inclusion Criteria:

• lung transplantation
• ≥ 18 years

Exclusion Criteria:

• < 18 years
• patient' s clinical conditions not allowing patient transport from ICU to Nuclear Medicine Unit

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Lung transplantated patients; Patients undergone lung transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients alive	up to 90 days from transplantation

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence of complications other than primary graft dysfunction	72 hours and 90 days
incidence of primary graft dysfunction	72 hours and 90 days after transplantation

Collaborators and Investigators

• Sponsor: Policlinico Hospital
• Investigators: Principal Investigator: davide chiumello, md, Policlinico Hospital; Principal Investigator: Franco Valenza, MD, Policlinico Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 11, 2012

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 201212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED