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Detecting Lesions in the Oral Cavity With Thermal Imaging

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00868725
First Posted: March 25, 2009
Last Update Posted: October 1, 2009
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.
Information provided by:
Sheba Medical Center
  Purpose
Previous studies indicate that there are significant differences in the temperature of tumors and normal, adjacent tissues. The present study will test this hypothesis for lesions in the oral cavity. Thermal images of the oral cavities of patients, undergoing examination in the Department of Oral and Maxillofacial Surgery of Sheba hospital, will be compared to the diagnoses of the examining doctors. The results, apart from enhancing the delineation of oral cavity tumors, may help the decision to develop miniature thermal cameras to scan thermally, the GI tract.

Condition Intervention
Carcinoma, Squamous Cell Other: no intervention, observation only

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Detecting Lesions in the Oral Cavity With Thermal Imaging

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Ability of a thermal camera to detect and delineate tumors in the oral cavity [ Time Frame: during and immediately after the examination ]

Estimated Enrollment: 50
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
possible oral cancer
Patients reporting for oral cavity examination with the possibility or certainty of oral lesions
Other: no intervention, observation only
Oral cavity will be imaged by a thermal camera.

  Eligibility

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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients reporting for oral cavity examination under the possibility of presenting with oral cavity lesions
Criteria

Inclusion Criteria:

  • Patients diagnosed in the Department of Oral and Maxillofacial Surgery as suffering from malignant or possibly malignant lesions.

Exclusion Criteria:

  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): NCT00868725


Locations
Israel
Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Arie Orenstein, Prof. Sheba Medical Center
  More Information

Publications:
Responsible Party: Prof. Arie Orenstein , Director Advanced Technologies Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00868725     History of Changes
Other Study ID Numbers: SHEBA-09-6870-AO-CTIL
First Submitted: March 24, 2009
First Posted: March 25, 2009
Last Update Posted: October 1, 2009
Last Verified: September 2009

Keywords provided by Sheba Medical Center:
oral cavity
carcinoma
thermal imaging

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell