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
- 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
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Diagnostic
Jenny T. Mao, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government