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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Rigshospitalet, Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01136265
First received: June 2, 2010
Last updated: January 10, 2011
Last verified: June 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Dep. of Nuclear Medicine & PET
Copenhagen, Denmark, 2100
Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet
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:
Lip Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Lip Diseases
Mouth Diseases
Neoplasms
Neoplasms by Site
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 22, 2014