NCT01136265

PET/CT and Sentinel Node in Oral Cancer

Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-06-01
• Completion: 2013-06-01
• First posted: 2010-06-03
• Last updated: 2011-01-11

Locations

2 sites across 1 country: Denmark