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PET/CT: Role in Detecting Unknown Primary Head and Neck Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00656760
First Posted: April 11, 2008
Last Update Posted: May 18, 2016
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.
Collaborator:
Tom Baker Cancer Centre
Information provided by (Responsible Party):
Joseph C. Dort, University of Calgary
  Purpose
Historically metastatic squamous cell carcinoma in a cervical lymph node from an occult primary malignancy of the head and neck was evaluated with panendoscopy and biopsies of high risk areas, such as the base of tongue, nasopharynx, and tonsils. This diagnostic protocol identifies the primary malignancy in about 50% of cases. In recent years, the availability of CT has slightly increased the detection rate to 65% when used as an adjunct to the traditional work-up. Studies using PET as an adjunct are conflicting with detection rates ranging up to 75%. Currently, no prospective study has analyzed the role of the PET-CT fusion in the work-up of an occult primary malignancy of the head and neck. This study will compare the detection rate of the traditional work-up to a new protocol involving a pre-operative diagnostic PET-CT.

Condition Intervention
Head and Neck Cancer Other: PET/CT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of Neck Nodes With an Unknown Primary Malignancy.

Resource links provided by NLM:


Further study details as provided by Joseph C. Dort, University of Calgary:

Primary Outcome Measures:
  • proportion of patients where PET/CT resulted in a change in diagnosis [ Time Frame: 2 weeks after surgery ]

Enrollment: 20
Study Start Date: July 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
All patients have PET/CT and biopsies with the surgeon blinded to the result of PET/CT. Additional biopsies are performed (or not) after the surgeon has the PET/CT results revealed.
Other: PET/CT
PET/CT is being performed on all patients in the study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Biopsy proven SCC in a cervical lymph node
  • Unknown primary cancer after: History, Physical exam, and office endoscopy by otolaryngologist
  • Negative Chest X-Ray for malignancy
  • Patient consent signed to undergo investigative protocol

Exclusion Criteria:

  • Un-fit for general anesthesia
  • Unable to lie flat for 45 minutes
  • Unable to fast for > 6 hours
  • Unable to perform PET-CT (Obesity > 150kg)
  • Pregnant
  • Prior Head and Neck cancer
  • Any invasive cancer (Non-Head and Neck) within the last 2 years
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00656760


Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
Tom Baker Cancer Centre
  More Information

Responsible Party: Joseph C. Dort, Professor of Surgery, University of Calgary
ClinicalTrials.gov Identifier: NCT00656760     History of Changes
Other Study ID Numbers: UCENT0001
First Submitted: April 7, 2008
First Posted: April 11, 2008
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Joseph C. Dort, University of Calgary:
unknown primary, head and neck cancer, squamous cell carcinoma
Unknown primary head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms