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

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ClinicalTrials.gov Identifier: NCT00656760
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
Tom Baker Cancer Centre
Information provided by (Responsible Party):
Joseph C. Dort, University of Calgary

Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Other: PET/CT Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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.
Study Start Date : July 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



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


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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

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

Responsible Party: Joseph C. Dort, Professor of Surgery, University of Calgary
ClinicalTrials.gov Identifier: NCT00656760     History of Changes
Other Study ID Numbers: UCENT0001
First Posted: April 11, 2008    Key Record Dates
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