PET/CT: Role in Detecting Unknown Primary Head and Neck Cancer
The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of Neck Nodes With an Unknown Primary Malignancy.
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable head-and-neck-cancer
Started Jul 2007
Typical duration for not_applicable head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 7, 2008
CompletedFirst Posted
Study publicly available on registry
April 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMay 18, 2016
May 1, 2016
3.7 years
April 7, 2008
May 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of patients where PET/CT resulted in a change in diagnosis
2 weeks after surgery
Study Arms (1)
A
EXPERIMENTALAll 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Tom Baker Cancer Centrecollaborator
Study Sites (1)
Tom Baker Cancer Centre
Calgary, Alberta, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
April 7, 2008
First Posted
April 11, 2008
Study Start
July 1, 2007
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
May 18, 2016
Record last verified: 2016-05