NCT00868725

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

October 1, 2009

Status Verified

September 1, 2009

Enrollment Period

2 months

First QC Date

March 24, 2009

Last Update Submit

September 30, 2009

Conditions

Carcinoma, Squamous Cell

Keywords

oral cavitycarcinomathermal imaging

Outcome Measures

Primary Outcomes (1)

  • Ability of a thermal camera to detect and delineate tumors in the oral cavity

    during and immediately after the examination

Study Arms (1)

possible oral cancer

Patients reporting for oral cavity examination with the possibility or certainty of oral lesions

Other: no intervention, observation only

Interventions

no intervention, observation onlyOTHER

Oral cavity will be imaged by a thermal camera.

possible oral cancer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients reporting for oral cavity examination under the possibility of presenting with oral cavity lesions

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related 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. doi: 10.1186/1471-2407-3-1. Epub 2003 Jan 6.

    PMID: 12515579BACKGROUND

MeSH Terms

Conditions

Carcinoma, Squamous CellCarcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Study Officials

  • Arie Orenstein, Prof.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 25, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 1, 2009

Record last verified: 2009-09

Locations

IL(1)