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

This study has been withdrawn prior to enrollment.
(Low interest)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00733252
First received: August 12, 2008
Last updated: March 21, 2012
Last verified: March 2012
  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
Nonmalignant Neoplasm
Precancerous Condition
Procedure: bronchoscopic and lung imaging studies
Procedure: diagnostic bronchoscopy
Procedure: histopathologic examination
Procedure: optical coherence tomography
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Optical Coherence Tomography of Human Airways

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

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


Enrollment: 0
Study Start Date: April 2008
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.
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
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Rana Hejal, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00733252     History of Changes
Other Study ID Numbers: CASE1508, P30CA043703, CASE1508, CASE-1508-CC483
Study First Received: August 12, 2008
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014