Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199615
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2005-09-14
Brief Title:
Follow-up of Patients With Curative-Intent Surgical Resection for NSCLC
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
Follow-up of Patients With Curative-Intent Surgical Resection for NSCLC CT Scanning Versus 18 FDG Imaging
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
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:
The guidelines and institutional practices recommended more frequent visits the two years following curative-intent therapy for non-small cell lung cancer NSCLCNo international consensus is published concerning follow-up of resected NSCLC patientsRecent studies have outlined that positron emission tomography PET scanning may be accurate in early detection of recurrences by comparison to computed tomography CT The aim of this study is to compare follow-up by conventional methods versus PET Patients are randomly assigned to two arms In the first arm thorax CT with liver and adrenal gland sections abdominal ultrasonography and nuclear bone scintigraphy are performed every 6 months after surgery for two years In the second arm PET scanning is only For brain metastasis detection CT is performed in the two arms Recurrences are detected during scheduled or unscheduled procedure in asymptomatic patients PET and CT are interpreted separately by two nuclear physicians and two radiologists The direct cost of follow-up procedure is determined in the two groups The calculated sample is composed of 60 patients in each arm to detect significant difference The Ethics Committee of Universitary Hospital of Limoges approves the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None