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

January 10, 2011 updated by: Rigshospitalet, Denmark

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.

Study Overview

Status

Unknown

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Dep. of Nuclear Medicine & PET
      • Copenhagen, Denmark, 2100
        • Dep. of otorhinolaryngology, Head & Neck Surgery/ Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Christine W Dümcke, Dr., Dep. of Nuclear Medicine & PET

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 2, 2010

First Posted (Estimate)

June 3, 2010

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH-238_10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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