PET/CT and Sentinel Node in Oral Cancer (PETNode)
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Copenhagen, Danmark, 2100
- Dep. of Nuclear Medicine & PET
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Copenhagen, Danmark, 2100
- Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- biopsy-verified oral cancer
- over 18 years of age
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christine W Dümcke, Dr., Dep. of Nuclear Medicine & PET
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RH-238_10
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