Morphofunctional Lung Analysis by PET and CT After Lung Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Policlinico Hospital
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT01746914
First received: December 7, 2012
Last updated: June 12, 2013
Last verified: June 2013
  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 Policlinico Hospital:

Primary Outcome Measures:
  • Number of patients alive [ Time Frame: up to 90 days from transplantation ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746914

Contacts
Contact: Davide Chiumello, MD +390255033237 chiumello@libero.it
Contact: Franco Valenza, MD +390255033232 franco.valenza@unimi.it

Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milano, Milan, Italy, 20122
Contact: Davide Chiumello, MD    +390255033237    chiumello@libero.it   
Contact: Franco Valenza, MD    +390255033232    franco.valenza@unimi.it   
Principal Investigator: Davide Chiumello, MD         
Principal Investigator: Franco Valenza, MD         
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Davide Chiumello, MD Policlinico Hospital
Principal Investigator: Franco Valenza, MD Policlinico Hospital
  More Information

No publications provided

Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT01746914     History of Changes
Other Study ID Numbers: 201212
Study First Received: December 7, 2012
Last Updated: June 12, 2013
Health Authority: Italy: Ministry of Health

ClinicalTrials.gov processed this record on August 20, 2014