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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

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.

Condition or disease
Oral Cancer

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

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer
Study Start Date : June 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Biospecimen Retention:   Samples With DNA
whole blood, primary cancer tissue, normal oral tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
70 consecutive patients with biopsy-verified oral cancer without a suspicion of metastases and without prior treated neck

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01136265

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Dep. of Nuclear Medicine & PET
Copenhagen, Denmark, 2100
Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Christine W Dümcke, Dr. Dep. of Nuclear Medicine & PET

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Responsible Party: Dr. Christine Winkler Duemcke, Dep. of Nuclear Medicine & PET, Rigshospitalet Identifier: NCT01136265     History of Changes
Other Study ID Numbers: RH-238_10
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: June 2010
Keywords provided by Rigshospitalet, Denmark:
dual-time PET/CT
sentinel node
Additional relevant MeSH terms:
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Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Lip Diseases