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Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT01136265
Study type Observational
Source Rigshospitalet, Denmark
Contact
Status Active, not recruiting
Phase N/A
Start date June 2010
Completion date June 2013

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