CancerPhase 2NBI-CABNCT01198119
Excision Limits of Oral Cavity Tumor by Narrow Band Imaging
A Phase 2 study testing Location of the suspected lesions, Biopsy and Lesion excision/Surgery in people with Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial summary
This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Location of the suspected lesions, Biopsy and Lesion excision/Surgery
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to 31 Dec 2014
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primitive epidermoid cancer of the oral cavity, proved by histology, not treated previously, patient having a surgery
- No previous surgery for this cancer
- Age > 18 years
- Patient affiliated to health insurance
- Consent signed by the patient
Who cannot join
- Metastatic or recurrent disease
- Health care impossibilities for geographic, social, psychic reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial
This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.
- Conditions
- Cancer
- Being tested
- Location of the suspected lesions, Biopsy, Lesion excision/Surgery
- Keywords
- oral cavity tumor, narrow band imaging, subclinical cancer lesion
- Medical subject headings
- Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Location of the suspected lesionsDevice
The suspected lesions will be located before the excision, during the surgery.
- With traditional light
- NBI technique The images will be recorded and compared
BiopsyProcedure or surgery
In case of suspected lesions detected by the NBI technique, this area is biopsied
Lesion excision/SurgeryProcedure or surgery
In case of positive biopsy, the suspected lesions is excised
| Study group | Role | What they receive |
|---|---|---|
| Patient with oral cavity cancer | Experimental | Patient treated by surgery for the oral cavity cancer Receives: Device: Location of the suspected lesions; Procedure: Biopsy; Procedure: Lesion excision/Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability for detection of subclinical lesions
Concordance between the histological data and the lesions detected by the NBI technique
Measured: baseline
Secondary outcomes (2)
Excision limits quality criteria
percentage of detection / percentage of false-negative
Measured: baseline
Detection of suspect lesions
Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2012
- Study completion31 Dec 2014
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie EL BEDOUI, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198119
- Sponsor's protocol ID
- NBI-CAB-0901
- Other IDs
- 2009-A01134-53
- Acronym
- NBI-CAB
- Status last verified
- Mar 2026
- First submitted
- 8 Sep 2010
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial
- ClinicalTrials.gov ID
- NCT01198119
- Acronym / sponsor ID
- NBI-CAB / NBI-CAB-0901
- Conditions
- Cancer
- Keywords
- oral cavity tumor, narrow band imaging, subclinical cancer lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 9 Sep 2010 (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.
This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with oral cavity cancer | Experimental | Device: Location of the suspected lesions, Procedure: Biopsy, Procedure: Lesion excision/SurgeryPatient treated by surgery for the oral cavity cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primitive epidermoid cancer of the oral cavity, proved by histology, not treated previously, patient having a surgery
- No previous surgery for this cancer
- Age > 18 years
- Patient affiliated to health insurance
- Consent signed by the patient
Key exclusion criteria (2 listed)
- Metastatic or recurrent disease
- Health care impossibilities for geographic, social, psychic reasons
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 |
|---|---|---|
| Location of the suspected lesionsThe suspected lesions will be located before the excision, during the surgery. 1. With traditional light 2. NBI technique The images will be recorded and compared | Device | Patient with oral cavity cancer |
| BiopsyIn case of suspected lesions detected by the NBI technique, this area is biopsied | Procedure or surgery | Patient with oral cavity cancer |
| Lesion excision/SurgeryIn case of positive biopsy, the suspected lesions is excised | Procedure or surgery | Patient with oral cavity cancer |
Primary outcome
Reliability for detection of subclinical lesions
Time frame: baseline
Concordance between the histological data and the lesions detected by the NBI technique
2 secondary outcomes
Excision limits quality criteria
Time frame: baseline
Detection of suspect lesions
Time frame: baseline
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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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.
Sophie EL BEDOUI, MD principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Location of the suspected lesions, Biopsy and Lesion excision/Surgery in people with Cancer, run by Centre Oscar Lambret at 1 site in France.
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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 16 Mar 2026. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
Reliability for detection of subclinical lesions (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.