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A Double-Blind, 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


Phase 3
N/A
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

A Double-Blind, 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


Inclusion Criteria:



- be suspected of having primary lung cancer based upon chest radiograph(s), CT
scan(s), or PET scan(s) and with symptom, risk profile, or history suggestive of
malignancy

- have FEV1 greater than or equal to 40% predicted normal for age and height

Exclusion Criteria:

- have obtained a confirmed diagnosis for the current suspicious lung tumor

- have been treated for the current, suspicious tumor except in cases in which the
current lesion is the recurrence of the same tumor (same location) for which
treatment was administered no less than 180 days prior to screening

- have undergone a bronchoscopic examination or pulmonary fine needle aspiration biopsy
within 4 days prior to dosing, or have undergone sputum induction within 3 days prior
to dosing

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Proportion of lung cancers (malignancies) diagnosed by sputum cytology

Principal Investigator

Amy Schaberg, BSN

Investigator Role:

Study Director

Authority:

United States: Food and Drug Administration

Study ID:

01-312

NCT ID:

NCT00210080

Start Date:

April 2001

Completion Date:

December 2003

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms

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