INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00033527|
Recruitment Status : Unknown
Verified September 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 22, 2003
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: INS316 Other: sputum cytology||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033527
|Study Chair:||Jenny T. Mao, MD||Jonsson Comprehensive Cancer Center|