Oral CancerPETNodeNCT01136265
PET/CT and Sentinel Node in Oral Cancer
An observational study of Oral Cancer, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
In this study, the investigators want to pre-operatively scan patients who do not have any clinically suspicion of metastases with an 18F-FDG-PET/CT whole body scan , where after they go to lymphoscintigraphy incl. SPECT/CT and sentinel node biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer
- How many people
- 70 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2010to Jun 2013
- 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: 70 consecutive patients with biopsy-verified oral cancer without a suspicion of metastases and without prior treated neck
Who may be able to join
- biopsy-verified oral cancer
- over 18 years of age
Who cannot join
- under 18 years of age
- inable patients
- pregnancy
- known allergy to contrast agents
- kidney insufficiency
- other known cancer
- diabetes mellitus
- acute medical conditions such as acute infection, acute cardial or lung disease or other intercurrent diseases
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dep. of Nuclear Medicine & PET
Copenhagen, 2100
Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet
Copenhagen, 2100
About this study
Official title: Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer
In this study, the investigators want to pre-operatively scan patients who do not have any clinically suspicion of metastases with an 18F-FDG-PET/CT whole body scan , where after they go to lymphoscintigraphy incl. SPECT/CT and sentinel node biopsy. Material from the oral cancer and, after permission of each patient, also normal oral tissue will be analyzed molecular-biologically. Also a blood sample will be analyzed for molecular tumor markers.
The investigators want to see if PET/CT is able to detect any signs of sub-clinically metastases. Besides, the investigators want to fusion PET/CT with SPECT/CT data from the lymphoscintigraphy study and improve our PET/CT scanning with a dual-time PET scan of the head-and-neck region.
Read the detailed description
These patients are normally preoperatively sent to a CT scan of the thorax and abdomen; in this study, this CT is replaced by a wholebody PET/CT scan. Afterwards, the patients goes to sentinel node lymphoscintigraphy and then to operation.
By combining biomarkers and molecular imaging in patients with a clinically T1/T2N0M0 oral cancer, we want to characterize the tumor physiologically and correlate these physiological features to the clinical appearance of the cancer.
Aims of the study:
- can PET/CT in this patient group metastases with consequently change of treatment?
- can fusion of SPECT/CT and PET/CT with calculation of standardized uptake value (SUV) indicate, how much tumor tissue there should be in a positive sentinel node to be detected by PET?
- can dual-time PET scanning better determine lymph node metastases, than single-time PET scanning?
- correlation between SUV in PET with molecular-biological findings both in the primary tumor and in metastases
- Conditions
- Oral Cancer
- Keywords
- dual-time PET/CT, sentinel node
- Medical subject headings
- Mouth Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Christine W Dümcke, Dr., Principal investigator, Dep. of Nuclear Medicine & PET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136265
- Sponsor's protocol ID
- RH-238_10
- Acronym
- PETNode
- Status last verified
- Jun 2010
- First submitted
- 2 Jun 2010
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer
- ClinicalTrials.gov ID
- NCT01136265
- Acronym / sponsor ID
- PETNode / RH-238_10
- Conditions
- Oral Cancer
- Keywords
- dual-time PET/CT, sentinel node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 3 Jun 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 investigators want to pre-operatively scan patients who do not have any clinically suspicion of metastases with an 18F-FDG-PET/CT whole body scan , where after they go to lymphoscintigraphy incl. SPECT/CT and sentinel node biopsy. Material from the oral cancer and, after permission of each patient, also normal oral tissue will be analyzed molecular-biologically. Also a blood sample will be analyzed for molecular tumor markers.
The investigators want to see if PET/CT is able to detect any signs of sub-clinically metastases. Besides, the investigators want to fusion PET/CT with SPECT/CT data from the lymphoscintigraphy study and improve our PET/CT scanning with a dual-time PET scan of the head-and-neck region.
Detailed description
These patients are normally preoperatively sent to a CT scan of the thorax and abdomen; in this study, this CT is replaced by a wholebody PET/CT scan. Afterwards, the patients goes to sentinel node lymphoscintigraphy and then to operation.
By combining biomarkers and molecular imaging in patients with a clinically T1/T2N0M0 oral cancer, we want to characterize the tumor physiologically and correlate these physiological features to the clinical appearance of the cancer.
Aims of the study:
- can PET/CT in this patient group metastases with consequently change of treatment?
- can fusion of SPECT/CT and PET/CT with calculation of standardized uptake value (SUV) indicate, how much tumor tissue there should be in a positive sentinel node to be detected by PET?
- can dual-time PET scanning better determine lymph node metastases, than single-time PET scanning?
- correlation between SUV in PET with molecular-biological findings both in the primary tumor and in metastases
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 consecutive patients with biopsy-verified oral cancer without a suspicion of metastases and without prior treated neck
Key inclusion criteria (2 listed)
- biopsy-verified oral cancer
- over 18 years of age
Key exclusion criteria (8 listed)
- under 18 years of age
- inable patients
- pregnancy
- known allergy to contrast agents
- kidney insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
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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.
Christine W Dümcke, Dr. principal investigator
Dep. of Nuclear Medicine & PET
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
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.
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 11 Jan 2011.