PET/CT and Sentinel Node in Oral Cancer

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Brief Title

PET/CT and Sentinel Node in Oral Cancer

Official Title

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

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 Type

Observational




Condition

Oral Cancer



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

70

Start Date

June 2010

Completion Date

June 2013

Primary Completion Date

June 2012

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christine W Dümcke, Dr., , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT01136265

Organization ID

RH-238_10



Study Sponsor

Rigshospitalet, Denmark


Study Sponsor

Christine W Dümcke, Dr., Principal Investigator, Dep. of Nuclear Medicine & PET


Verification Date

June 2010