INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: INS316 Other: sputum cytology Not Applicable

Detailed Description:


  • 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)
Allocation: Randomized
Masking: Double
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Suspected of having primary lung cancer by chest radiography, CT scan, or positron-emission tomography scan with symptoms, risk profile, or history suggestive of malignancy
  • No prior confirmed diagnosis for current suspicious lung tumor
  • Expected to have a histological or cytological confirmation within 8 weeks after study completion
  • No prior treatment for current suspicious tumor unless current lesion is recurrence of same tumor (in same location) for which prior treatment was received at least 180 days prior to study
  • FEV_1 at least 40% predicted



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent comorbid condition that would preclude study participation


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics


  • See Disease Characteristics


  • At least 4 days since prior pulmonary fine needle aspiration biopsy
  • No concurrent mediastinoscopy or thoracotomy


  • At least 4 days since prior bronchoscopic examination
  • At least 3 days since prior sputum induction
  • At least 30 days since prior investigational drugs (including INS316) or experimental therapy
  • No concurrent medication that would preclude study participation

Information from the National Library of Medicine

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 identifier (NCT number): NCT00033527

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Jenny T. Mao, MD Jonsson Comprehensive Cancer Center Identifier: NCT00033527     History of Changes
Other Study ID Numbers: CDR0000069297
First Posted: October 22, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: September 2002

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer
small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases