Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008255
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-01-06
Brief Title:
INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluation Of Uridine 5-Triphosphate Solution For Inhalation UTP As An Adjunct In The Diagnosis Of Lung Cancer By Sputum Cytology
Status:
COMPLETED
Status Verified Date:
2001-05
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:
RATIONALE Doctors can diagnose lung cancer by collecting mucus coughed up from the lungs and examining it under a microscope to look for cancer cells Breathing in INS316 may make it easier for patients to cough up mucus
PURPOSE Randomized phase II trial to study the effectiveness of INS316 in helping to diagnose lung cancer
PURPOSE Randomized phase II trial to study the effectiveness of INS316 in helping to diagnose lung cancer
Detailed Description:
OBJECTIVES I Determine whether a cytological diagnosis of lung cancer can be obtained more frequently from sputum specimens following inhalation of INS316 compared to specimens obtained following placebo or compared to specimens spontaneously expectorated in patients with untreated lung cancer II Assess the relative sensitivity of sputum cytology in the diagnosis of lung malignancies in this patient population using these sputum collection regimens III Determine the quantity of macrophages in sputum of these patients using these techniques IV Determine if the number of macrophages in sputum obtained by these methods is predictive of the likelihood of obtaining a positive diagnosis of lung cancer in these patients V Determine the total amount of sputum expectorated from these patients using these techniques
OUTLINE This is a randomized double-blind placebo-controlled cross-over multicenter study Patients are randomized to one of two arms then cross-over to the other arm Arm I Patients receive INS316 by inhalation via a nebulizer Sputum is collected throughout the dosing and for 1 hour post dosing Arm II Patients receive placebo in the same manner as INS136 in arm I All patients receive both treatments Patients receive the first dose no more than 7 days after screening and the second dose 3 to 10 days after the first dose Patients are followed 1 day after completion of the second treatment The sputum samples are fixed and examined cytologically
PROJECTED ACCRUAL Approximately 100-130 patients will be accrued for this study
OUTLINE This is a randomized double-blind placebo-controlled cross-over multicenter study Patients are randomized to one of two arms then cross-over to the other arm Arm I Patients receive INS316 by inhalation via a nebulizer Sputum is collected throughout the dosing and for 1 hour post dosing Arm II Patients receive placebo in the same manner as INS136 in arm I All patients receive both treatments Patients receive the first dose no more than 7 days after screening and the second dose 3 to 10 days after the first dose Patients are followed 1 day after completion of the second treatment The sputum samples are fixed and examined cytologically
PROJECTED ACCRUAL Approximately 100-130 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068391 | REGISTRY | None | None |
| NCI-G00-1894 | Registry Identifier | PDQ Physician Data Query | None |