Carcinoma, Squamous CellNCT00868725
Detecting Lesions in the Oral Cavity With Thermal Imaging
An observational study of Carcinoma, Squamous Cell, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Squamous Cell
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients reporting for oral cavity examination under the possibility of presenting with oral cavity lesions
Who may be able to join
- Patients diagnosed in the Department of Oral and Maxillofacial Surgery as suffering from malignant or possibly malignant lesions.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- no intervention, observation only
- Keywords
- oral cavity, carcinoma, thermal imaging
- Medical subject headings
- Carcinoma, Squamous Cell, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, observation onlyOther
Oral cavity will be imaged by a thermal camera.
| Study group | Role | What they receive |
|---|---|---|
| possible oral cancer | Patients reporting for oral cavity examination with the possibility or certainty of oral lesions Receives: Other: no intervention, observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of a thermal camera to detect and delineate tumors in the oral cavity
Measured: during and immediately after the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Arie Orenstein, Prof., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868725
- Sponsor's protocol ID
- SHEBA-09-6870-AO-CTIL
- Status last verified
- Sep 2009
- First submitted
- 24 Mar 2009
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1186/1471-2407-3-1. Epub 2003 Jan 6.
PubMed 12515579
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Lesions in the Oral Cavity With Thermal Imaging
- ClinicalTrials.gov ID
- NCT00868725
- Acronym / sponsor ID
- SHEBA-09-6870-AO-CTIL
- Conditions
- Carcinoma, Squamous Cell
- Keywords
- oral cavity, carcinoma, thermal imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| possible oral cancer | – | Other: no intervention, observation onlyPatients reporting for oral cavity examination with the possibility or certainty of oral lesions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients reporting for oral cavity examination under the possibility of presenting with oral cavity lesions
Key inclusion criteria (1 listed)
- Patients diagnosed in the Department of Oral and Maxillofacial Surgery as suffering from malignant or possibly malignant lesions.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention, observation onlyOral cavity will be imaged by a thermal camera. | Other | possible oral cancer |
Primary outcome
Ability of a thermal camera to detect and delineate tumors in the oral cavity
Time frame: during and immediately after the examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2009.
- Background: PubMed 12515579Stefanadis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arie Orenstein, Prof. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Squamous Cell, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of a thermal camera to detect and delineate tumors in the oral cavity (time frame: during and immediately after the examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00868725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2009.