Overview

This trial is active, not recruiting.

Condition oral cancer
Sponsor Rigshospitalet, Denmark
Start date June 2010
End date June 2012
Trial size 70 participants
Trial identifier NCT01136265, RH-238_10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.