PET/CT and Sentinel Node in Oral Cancer (PETNode)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136265
Recruitment Status : Unknown
Verified June 2010 by Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2010
Last Update Posted : January 11, 2011
Information provided by:
Rigshospitalet, Denmark

June 2, 2010
June 3, 2010
January 11, 2011
June 2010
June 2012   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01136265 on Archive Site
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PET/CT and Sentinel Node in Oral Cancer
Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer

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.

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
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
whole blood, primary cancer tissue, normal oral tissue
Non-Probability Sample
70 consecutive patients with biopsy-verified oral cancer without a suspicion of metastases and without prior treated neck
Oral Cancer
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2013
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Dr. Christine Winkler Duemcke, Dep. of Nuclear Medicine & PET, Rigshospitalet
Rigshospitalet, Denmark
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Principal Investigator: Christine W Dümcke, Dr. Dep. of Nuclear Medicine & PET
Rigshospitalet, Denmark
June 2010