PET/CT and Sentinel Node in Oral Cancer
This trial is active, not recruiting.
|Start date||June 2010|
|End date||June 2012|
|Trial size||70 participants|
|Trial identifier||NCT01136265, RH-238_10|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
Male or female participants at least 18 years old.
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
|Official title||Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer|
|Principal investigator||Christine W Dümcke, Dr.|
|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|
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