Detecting Lesions in the Oral Cavity With Thermal Imaging | NCT00868725

Studies
Detecting Lesions in the Oral Cavity With Thermal Imaging

NCT00868725

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Oct 1, 2009Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Carcinoma, Squamous Cell

Interventions

no intervention, observation only

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Mar 24, 2009

First Submission Date that Met QC Criteria

Mar 24, 2009

First Posted Date

Mar 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2009

Last Update Posted Date

Oct 1, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
possible oral cancer		Patients reporting for oral cavity examination with the possibility or certainty of oral lesions	Other: no intervention, observation only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention, observation only	Other	Oral cavity will be imaged by a thermal camera.	possible oral cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ability of a thermal camera to detect and delineate tumors in the oral cavity		during and immediately after the examination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arie Orenstein, Prof.	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Tel Litwinsky		52621	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12515579	Background	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.

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018307	Neoplasms, Squamous Cell

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma