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

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.
ClinicalTrials.gov Identifier: NCT00733252
Recruitment Status : Withdrawn (Low interest)
First Posted : August 13, 2008
Last Update Posted : October 2, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Lung Cancer Malignant Mesothelioma Metastatic Cancer Nonmalignant Neoplasm Precancerous Condition Procedure: bronchoscopic and lung imaging studies Procedure: diagnostic bronchoscopy Procedure: histopathologic examination Procedure: optical coherence tomography Phase 1

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.


Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Optical Coherence Tomography of Human Airways
Study Start Date : April 2008
Primary Completion Date : January 2011
Study Completion Date : February 2011


Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Correlation of optical coherence tomography images of the airway with airway histology [ Time Frame: This study will involve discarded tissue from 10 subjects with pathology specimens over one year. ]

Biospecimen Retention:   Samples Without DNA
Fresh Bronchi from 10 subjects undergoing pneumonectomy or lobectomy for malignant and benign processes will be obtained from the UHCMC Pathology Department as discarded tissue from fresh specimens

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care clinic
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

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 ClinicalTrials.gov identifier (NCT number): NCT00733252


Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Rana Hejal, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
More Information

Additional Information:
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00733252     History of Changes
Other Study ID Numbers: CASE1508
P30CA043703 ( U.S. NIH Grant/Contract )
CASE1508 ( Other Identifier: Case Comprehensive Cancer Center )
CASE-1508-CC483
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015

Keywords provided by Case Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Lung Neoplasms
Mesothelioma
Neoplasm Metastasis
Precancerous Conditions
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Neoplastic Processes
Pathologic Processes