Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033527
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2002-04-09
Brief Title:
INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Double-Blinded Placebo-Controlled Parallel Group Study Of Uridine 5-Triphosphate UTP Solution For Inhalation As An Adjunct In The Diagnosis Of Lung Cancer By Sputum Cytology
Status:
UNKNOWN
Status Verified Date:
2002-09
Last Known Status:
ACTIVE_NOT_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:
RATIONALE INS316 may produce a better sputum sample for laboratory analysis and may provide a less invasive method of diagnosing lung cancer
PURPOSE Randomized diagnostic trial to compare the effectiveness of INS316 with that of saline for sputum collection in diagnosing lung cancer in patients suspected of having lung cancer
PURPOSE Randomized diagnostic trial to compare the effectiveness of INS316 with that of saline for sputum collection in diagnosing lung cancer in patients suspected of having lung cancer
Detailed Description:
OBJECTIVES
Compare the number of lung cancer diagnoses obtained from cytological evaluation of sputum expectorated after inhalation of INS316 versus normal saline as an adjunct for spontaneous expectoration of sputum in patients with suspected lung cancer
Compare the relative sensitivity of sputum cytology in the diagnosis of primary lung cancer using these methods of sputum collection in these patients
Compare the amount of sputum collected from patients using these methods
Correlate the number of macrophages in sputum with the predictive likelihood of obtaining a positive diagnosis by sputum cytology in these patients
Determine whether specificity of sputum cytology is adversely affected by induction with INS316 in these patients
OUTLINE This is a randomized double-blind placebo-controlled parallel multicenter study Patients are stratified according to tumor size and location as visualized by chest radiography CT scan or positron-emission tomography scan peripheral tumor distal to the subsegmental bronchi no greater than 2 cm in diameter vs peripheral tumor greater than 2 cm in diameter vs central tumor no greater than 2 cm in diameter vs central tumor greater than 2 cm in diameter Patients are randomized to one of two arms
Prior to dosing with sputum induction adjunct all patients expectorate sputum spontaneously
Arm I Patients receive a single dose of INS316 by inhalation
Arm II Patients receive a single dose of placebo normal saline by inhalation
In both arms patients expectorate sputum during dosing immediately after dosing and then within 15 30 and 60 minutes after dosing
Patients are followed on day 1 after dosing for up to 8 weeks until a diagnosis is made and then up to 3 months if diagnosis is malignant
PROJECTED ACCRUAL Approximately 800 patients or until 600 confirmed diagnoses of malignancy are made will be accrued for this study
Compare the number of lung cancer diagnoses obtained from cytological evaluation of sputum expectorated after inhalation of INS316 versus normal saline as an adjunct for spontaneous expectoration of sputum in patients with suspected lung cancer
Compare the relative sensitivity of sputum cytology in the diagnosis of primary lung cancer using these methods of sputum collection in these patients
Compare the amount of sputum collected from patients using these methods
Correlate the number of macrophages in sputum with the predictive likelihood of obtaining a positive diagnosis by sputum cytology in these patients
Determine whether specificity of sputum cytology is adversely affected by induction with INS316 in these patients
OUTLINE This is a randomized double-blind placebo-controlled parallel multicenter study Patients are stratified according to tumor size and location as visualized by chest radiography CT scan or positron-emission tomography scan peripheral tumor distal to the subsegmental bronchi no greater than 2 cm in diameter vs peripheral tumor greater than 2 cm in diameter vs central tumor no greater than 2 cm in diameter vs central tumor greater than 2 cm in diameter Patients are randomized to one of two arms
Prior to dosing with sputum induction adjunct all patients expectorate sputum spontaneously
Arm I Patients receive a single dose of INS316 by inhalation
Arm II Patients receive a single dose of placebo normal saline by inhalation
In both arms patients expectorate sputum during dosing immediately after dosing and then within 15 30 and 60 minutes after dosing
Patients are followed on day 1 after dosing for up to 8 weeks until a diagnosis is made and then up to 3 months if diagnosis is malignant
PROJECTED ACCRUAL Approximately 800 patients or until 600 confirmed diagnoses of malignancy are made 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 |
|---|---|---|---|
| NCI-G02-2055 | None | None | None |
| UCLA-010302101 | None | None | None |
| IP-01-312 | None | None | None |