Trial Information
The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of Neck Nodes With an Unknown Primary Malignancy.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic
Outcome Measure:
proportion of patients where PET/CT resulted in a change in diagnosis
Outcome Time Frame:
2 weeks after surgery
Safety Issue:
No
Authority:
Canada: Ethics Review Committee
Study ID:
UCENT0001
NCT ID:
NCT00656760
Start Date:
July 2007
Completion Date:
March 2011
Related Keywords:
- Head and Neck Cancer
- unknown primary, head and neck cancer, squamous cell carcinoma
- Unknown primary head and neck cancer
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms