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

This study has been completed.
Sponsor:
Collaborator:
Tom Baker Cancer Centre
Information provided by (Responsible Party):
Joseph C. Dort, University of Calgary
ClinicalTrials.gov Identifier:
NCT00656760
First received: April 7, 2008
Last updated: August 22, 2011
Last verified: April 2008
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
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 University of Calgary:

Primary Outcome Measures:
  • proportion of patients where PET/CT resulted in a change in diagnosis [ Time Frame: 2 weeks after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00656760

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

No publications provided

Responsible Party: Joseph C. Dort, Professor of Surgery, University of Calgary
ClinicalTrials.gov Identifier: NCT00656760     History of Changes
Other Study ID Numbers: UCENT0001
Study First Received: April 7, 2008
Last Updated: August 22, 2011
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on August 25, 2014