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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01136265
First received: June 2, 2010
Last updated: January 10, 2011
Last verified: June 2010
History of Changes

June 2, 2010
January 10, 2011
June 2010
June 2012   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01136265 on ClinicalTrials.gov 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
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01136265
RH-238_10
No
Dr. Christine Winkler Duemcke, Dep. of Nuclear Medicine & PET, Rigshospitalet
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Christine W Dümcke, Dr. Dep. of Nuclear Medicine & PET
Rigshospitalet, Denmark
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP