PET/CT and Sentinel Node in Oral Cancer (PETNode)
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|ClinicalTrials.gov Identifier: NCT01136265|
Recruitment Status : Unknown
Verified June 2010 by Rigshospitalet, Denmark.
Recruitment status was: Active, not recruiting
First Posted : June 3, 2010
Last Update Posted : January 11, 2011
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.
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2013|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136265
|Dep. of Nuclear Medicine & PET|
|Copenhagen, Denmark, 2100|
|Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Christine W Dümcke, Dr.||Dep. of Nuclear Medicine & PET|