Morphofunctional Lung Analysis by PET and CT After Lung Transplantation

Disorder Related to Lung Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746914
• Other study ID #: 201212
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: March 29, 2016
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disorder Related to Lung Transplantation

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients alive		up to 90 days from transplantation	No
Secondary	incidence of complications other than primary graft dysfunction		72 hours and 90 days	Yes
Secondary	incidence of primary graft dysfunction		72 hours and 90 days after transplantation	Yes