Squamous Cell Carcinoma of the Oral CavityNCT01077869
A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis
An observational study of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Metastases, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oral Cavity, Oropharynx Metastases, Lymph Metastases
- What is being tested?
- endoscopic examination and FDG-PET
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2010to May 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Squamous cell carcinoma of the oral cavity, oropharynx and lymph node metastases from unknown primary tumor.
Who may be able to join
- Non-operated histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx (except the posterior wall) and lymph node metastases from the unknown primary tumor (CUP)
- Stage T1-4; Tx N+ for the CUP
- Multidisciplinary Group of Head and Neck Tumors at Ghent University Hospital decision of radical radiotherapy (±concurrent chemotherapy)
- Informed consent obtained, signed and dated before specific protocol procedures.
Who cannot join
- Age < 18 years
- Pregnant or lactating women
- Active infection or fistula in the oral/oropharyngeal mucosa
- Previous cancer of the oral cavity and the oropharynx
- Prior head-and-neck radiotherapy
- Expectation of non-compliance with the study protocol
- Known allergy for topical anesthetics (Xylocaïne)
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.
- Being tested
- endoscopic examination, FDG-PET
- Keywords
- oropharynx and lymph node metastases from an unknown primary tumor
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic examinationProcedure or surgery
on a weekly basis during 7 weeks
FDG-PETProcedure or surgery
once pre-radiotherapy and once 2 weeks after initiation of radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of optical imaging in the evaluation of radiation-induced mucositis.
Measured: weekly assessment during 7 weeks
Feasibility of FDG-PET in the evaluation of radiation-induced mucositis.
Measured: 2 weeks after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: poor recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Oral CavityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- wilfried De Neve, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077869
- Sponsor's protocol ID
- 2009/621
- Status last verified
- May 2011
- First submitted
- 25 Feb 2010
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis
- ClinicalTrials.gov ID
- NCT01077869
- Acronym / sponsor ID
- 2009/621
- Keywords
- oropharynx and lymph node metastases from an unknown primary tumor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: poor recruitment rate
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Mar 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.
In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Squamous cell carcinoma of the oral cavity, oropharynx and lymph node metastases from unknown primary tumor.
Key inclusion criteria (4 listed)
- Non-operated histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx (except the posterior wall) and lymph node metastases from the unknown primary tumor (CUP)
- Stage T1-4; Tx N+ for the CUP
- Multidisciplinary Group of Head and Neck Tumors at Ghent University Hospital decision of radical radiotherapy (±concurrent chemotherapy)
- Informed consent obtained, signed and dated before specific protocol procedures.
Key exclusion criteria (7 listed)
- Age < 18 years
- Pregnant or lactating women
- Active infection or fistula in the oral/oropharyngeal mucosa
- Previous cancer of the oral cavity and the oropharynx
- Prior head-and-neck radiotherapy
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 |
|---|---|---|
| endoscopic examinationon a weekly basis during 7 weeks | Procedure or surgery | – |
| FDG-PETonce pre-radiotherapy and once 2 weeks after initiation of radiotherapy | Procedure or surgery | – |
Primary outcome
Feasibility of optical imaging in the evaluation of radiation-induced mucositis.
Time frame: weekly assessment during 7 weeks
Feasibility of FDG-PET in the evaluation of radiation-induced mucositis.
Time frame: 2 weeks after radiotherapy
Results and safety
The study was stopped early (reason given: poor recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2011.
- website University Hospital GhentLink provided by the sponsor.
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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.
wilfried De Neve, MD, PhD principal investigator
University Hospital, Ghent
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 Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Metastases, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 7 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 26 May 2011. 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 Belgium. 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 was stopped early (reason given: poor recruitment rate). 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?
Feasibility of optical imaging in the evaluation of radiation-induced mucositis. (time frame: weekly assessment during 7 weeks). The study lists 2 primary outcomes in all. 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 26 May 2011.