Detecting Lesions in the Oral Cavity With Thermal Imaging

This study is not yet open for participant recruitment.

Verified by Sheba Medical Center, March 2009

First Received: March 24, 2009 No Changes Posted

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00868725

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

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2009
Estimated 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

Contacts

Contact: Arie Orenstein, Prof.	+97235303114	gidi.arbel@sheba.health.gov.il
Contact: Gidi Arbel, Dr.	+97254838960	gidi.arbel@sheba.health.gov.il

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:

Stefanadis C, Chrysohoou C, Panagiotakos DB, Passalidou E, Katsi V, Polychronopoulos V, Toutouzas PK. Temperature differences are associated with malignancy on lung lesions: a clinical study. BMC Cancer. 2003 Jan 6;3:1. Epub 2003 Jan 6.

Responsible Party:	Sheba Medical Center ( Prof. Arie Orenstein , Director Advanced Technologies Center )
Study ID Numbers:	SHEBA-09-6870-AO-CTIL
Study First Received:	March 24, 2009
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00868725 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Sheba Medical Center:

oral cavity
carcinoma
thermal imaging

Study placed in the following topic categories:

Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Squamous Cell

Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009