PET/CT and Sentinel Node in Oral Cancer

• Conditions: Oral Cancer

• Registration Number: NCT01136265
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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

Study Timeline

• Status Verified: 2010-06
• Study Start: 2010-06
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Last Update Submitted: 2011-01-10
• Last Update Posted: 2011-01-11
• Primary Completion: 2012-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Dep. of Nuclear Medicine & PET; 🇩🇰 Copenhagen, Denmark