Optical Coherence Tomography of the Airway in Detecting Abnormal Cells in Patients Undergoing Surgery for Lung Cancer or Lung Disease

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), December 2008

First Received: August 12, 2008 Last Updated: February 6, 2009 History of Changes

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00733252

Purpose

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.

Condition	Intervention	Phase
Lung Cancer Malignant Mesothelioma Metastatic Cancer Precancerous/Nonmalignant Condition	Procedure: bronchoscopic and lung imaging studies Procedure: diagnostic bronchoscopy Procedure: histopathologic examination Procedure: optical coherence tomography	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Optical Coherence Tomography of Human Airways

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Mesothelioma Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Correlation of optical coherence tomography images of the airway with airway histology [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	April 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Undergoing pneumonectomy or lobectomy for malignant or benign lung processes

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733252

Locations

United States, Ohio
Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422
Geauga Regional Hospital	Recruiting
Cleveland, Ohio, United States, 44024
Contact: Jeffrey Kern 216-844-8101
Lake/University Ireland Cancer Center	Recruiting
Cleveland, Ohio, United States, 44060
Contact: Jeffrey Kern 216-844-8101
Mercy Cancer Center at Mercy Medical Center	Recruiting
Cleveland, Ohio, United States, 44708
Contact: Jeffrey Kern 216-844-8101
University Suburban Health Center	Recruiting
Cleveland, Ohio, United States, 44121
Contact: Jeffrey Kern 216-844-8101
UHHS Chagrin Highlands Medical Center	Recruiting
Cleveland, Ohio, United States, 44122
Contact: Jeffrey Kern 216-844-8101
UHHS Westlake Medical Center	Recruiting
Cleveland, Ohio, United States, 44145
Contact: Jeffrey Kern 216-844-8101
Southwest General Health Center	Recruiting
Cleveland, Ohio, United States, 44130
Contact: Jeffrey Kern 216-844-8101

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jeffrey A. Kern, MD

Ireland Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000601588, CASE-1508, CASE-1508-CC483
Study First Received:	August 12, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00733252 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

non-small cell lung cancer
small cell lung cancer
benign respiratory tract neoplasm
lung papilloma
recurrent respiratory papillomatosis

squamous lung dysplasia
malignant mesothelioma
pulmonary carcinoid tumor
lung metastases

Study placed in the following topic categories:

Thoracic Neoplasms
Precancerous Conditions
Recurrence
Carcinoma, Small Cell
Respiratory Tract Diseases
Recurrent Respiratory Papillomatosis
Lung Neoplasms
Lung Diseases

Neoplasm Metastasis
Non-small Cell Lung Cancer
Mesothelioma
Carcinoid Tumor
Papilloma
Carcinoma, Non-Small-Cell Lung
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions
Neoplasms, Mesothelial
Neoplastic Processes
Neoplasms
Pathologic Processes

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 25, 2009