Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023465
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-09-06
Brief Title:
Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It has been shown that neutrophils a specific type of cell are involved in inflammation in the lungs of CF patients Neutrophil levels in CF patients have been measured by bronchoalveolar lavage BAL which samples cells in the fluid lining of the lungs Other studies have measured neutrophil levels and inflammation in other parts of the body using PET scanning This study aims to show that PET scanning can be used as a non-invasive marker of inflammation in the lungs of patients with CF which would be a useful tool in treatment
The primary goal of this study is to draw a connection between the level of inflammation shown in the PET scan and the number of neutrophils obtained from the BAL This study will also look at how the PET images relate to inflammatory molecules in the lungs and to the FEV-1 obtained through spirometry
The primary goal of this study is to draw a connection between the level of inflammation shown in the PET scan and the number of neutrophils obtained from the BAL This study will also look at how the PET images relate to inflammatory molecules in the lungs and to the FEV-1 obtained through spirometry
Detailed Description:
All patients involved in the study will have a PET scan performed This involves injecting a small amount of radiolabelled glucose sugar into the blood A scan will then be performed to obtain an image of where in the body that glucose is being used Patients will also have spirometry done Spirometry is a simple procedure measuring the functioning of the lungs FEV-1 by measuring the amount of air a patient can blow out and inhale the patient breathes into a machine Bronchoalveolar lavage BAL will be performed This involves putting a small amount of fluid into a section of the lung then suctioning it out to retrieve the cells and molecules contained in the substance lining the lung
Subjects will be patients with cystic fibrosis Ten subjects will be stable with either mild or moderate disease These subjects will receive a PET scan spirometry and BAL
This portion of the study is made up of 10 stable CF patients 5 of whom will have mild disease and 5 of whom will have moderate disease These patients will receive a PET scan spirometry and a BAL over 2 consecutive days On day 1 patients will have a PET scan and spirometry On day 2 patients will have a BAL
Patients will arrive on the first day after fasting for at least 6 hours and will be taken to the PET facility PET scanning consists of a 2-minute scan followed by a 15-minute scan injection of radiolabelled sugar into the vein and 66 minutes of scanning The patient will then be instructed to empty his or her bladder to reduce total radiation exposure The patient will then be given a meal Next the patient will be taken for spirometry the last test of day 1 which simple involves breathing into a machine that measures the amount of air inhaled and exhaled Upon reporting to the GCRC on day 2 the patient will be taken for a BAL the patient will have fasted for at least 6 hours prior to admission BAL involves a small tube placed into the mouth down the throat and into the lung lidocaine is used to numb the entire area Less than 3 tablespoons of saline salt water is poured down the tube then immediately sucked back up and collected by the doctor This is repeated twice for a total of 8 tablespoons of liquid
Subjects will be patients with cystic fibrosis Ten subjects will be stable with either mild or moderate disease These subjects will receive a PET scan spirometry and BAL
This portion of the study is made up of 10 stable CF patients 5 of whom will have mild disease and 5 of whom will have moderate disease These patients will receive a PET scan spirometry and a BAL over 2 consecutive days On day 1 patients will have a PET scan and spirometry On day 2 patients will have a BAL
Patients will arrive on the first day after fasting for at least 6 hours and will be taken to the PET facility PET scanning consists of a 2-minute scan followed by a 15-minute scan injection of radiolabelled sugar into the vein and 66 minutes of scanning The patient will then be instructed to empty his or her bladder to reduce total radiation exposure The patient will then be given a meal Next the patient will be taken for spirometry the last test of day 1 which simple involves breathing into a machine that measures the amount of air inhaled and exhaled Upon reporting to the GCRC on day 2 the patient will be taken for a BAL the patient will have fasted for at least 6 hours prior to admission BAL involves a small tube placed into the mouth down the throat and into the lung lidocaine is used to numb the entire area Less than 3 tablespoons of saline salt water is poured down the tube then immediately sucked back up and collected by the doctor This is repeated twice for a total of 8 tablespoons of liquid
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: