Detecting Lesions in the Oral Cavity With Thermal Imaging

Carcinoma, Squamous Cell Clinical Trial

Official title:

Detecting Lesions in the Oral Cavity With Thermal Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868725
• Other study ID #: SHEBA-09-6870-AO-CTIL
• Status: Completed
• Phase: N/A
• First received: March 24, 2009
• Last updated: September 30, 2009
• Start date: April 2009
• Est. completion date: June 2009

Study information

• Verified date: September 2009
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell

Intervention

Other:
• no intervention, observation only
Oral cavity will be imaged by a thermal camera.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of a thermal camera to detect and delineate tumors in the oral cavity		during and immediately after the examination	No