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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Other: PET/CT

• Registration Number: NCT00656760
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-11
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	PET/CT	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.

Primary Outcome Measures

Name	Time	Method
proportion of patients where PET/CT resulted in a change in diagnosis	2 weeks after surgery

Trial Locations

Locations (1)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada