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Detecting Lesions in the Oral Cavity With Thermal Imaging

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00868725
First received: March 24, 2009
Last updated: September 30, 2009
Last verified: September 2009
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 24, 2009
Last Updated: September 30, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013