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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
  Purpose

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
Oral Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dual-time PET/CT and Sentinel Node Diagnostics Preoperatively in Patients With Oral Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Biospecimen Retention:   Samples With DNA

whole blood, primary cancer tissue, normal oral tissue


Estimated Enrollment: 70
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136265

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

No publications provided

Responsible Party: Dr. Christine Winkler Duemcke, Dep. of Nuclear Medicine & PET, Rigshospitalet
ClinicalTrials.gov Identifier: NCT01136265     History of Changes
Other Study ID Numbers: RH-238_10
Study First Received: June 2, 2010
Last Updated: January 10, 2011
Health Authority: Denmark: National Board of Health
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
dual-time PET/CT
sentinel node

Additional relevant MeSH terms:
Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases

ClinicalTrials.gov processed this record on May 16, 2013