Optical Coherence Tomography of the Airway for Lung Cancer or Lung Disease
This study has been withdrawn prior to enrollment.
(Low interest)
Sponsor:
Case Comprehensive Cancer Center
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
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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:
Detailed Description:
-
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.
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
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 June 18, 2013