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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/CT

Other

PET/CT is being performed on all patients in the study.

Primary outcomes

proportion of patients where PET/CT resulted in a change in diagnosis

Time frame: 2 weeks after surgery

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

Tom Baker Cancer Centre

Registry information

Official study title

The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of Neck Nodes With an Unknown Primary Malignancy.

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Apr 11, 2008
Registry last updated: May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed