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NCT00733252 Clinical Trial

Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease

Lung Cancer Clinical Trial

Official title:
Optical Coherence Tomography of Human Airways

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00733252
Other study ID # CASE1508
Secondary ID P30CA043703CASE1
Status Withdrawn
Phase Phase 1
First received August 12, 2008
Last updated October 1, 2015
Start date April 2008
Est. completion date February 2011

Study information
Verified date October 2015
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as optical coherence tomography, may help find and diagnose lung cancer or precancerous cells.

PURPOSE: This phase I trial is studying how well optical coherence tomography of the airway works in detecting abnormal cells in patients undergoing surgery for lung cancer or lung disease.

Description:

OBJECTIVES:

- Correlate optical coherence tomography images of the airway with airway histology.

- Develop an imaging technique to detect premalignant airway epithelial changes (carcinoma in situ, dysplasia) to study the transformation process as well as intervene and prevent the development of lung cancer.

OUTLINE: Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery. All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Undergoing pneumonectomy or lobectomy for malignant or benign lung processes

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• bronchoscopic and lung imaging studies
Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.
• diagnostic bronchoscopy
Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.
• histopathologic examination
All imaged areas are marked. The marked areas are then excised and fixed in formalin for histopathologic analysis.
• optical coherence tomography
Bronchoscopic imaging and optical coherence tomography are performed on lung tissue samples collected during surgery.

Locations
Country Name City State
United States Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (2)
Lead Sponsor Collaborator
Case Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of optical coherence tomography images of the airway with airway histology This study will involve discarded tissue from 10 subjects with pathology specimens over one year. No
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