Back to resultsPET/CT: Role in Detecting Unknown Primary Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring unknown primary, head and neck cancer, squamous cell carcinoma, Unknown primary head and neck cancer
Eligibility 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
Sites / Locations
- Tom Baker Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
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.
Outcomes
Primary Outcome Measures
proportion of patients where PET/CT resulted in a change in diagnosis
Secondary Outcome Measures
Full Information
NCT ID
NCT00656760
First Posted
April 7, 2008
Last Updated
May 17, 2016
Sponsor
University of Calgary
Collaborators
Tom Baker Cancer Centre
1. Study Identification
Unique Protocol Identification Number
NCT00656760
Brief Title
PET/CT: Role in Detecting Unknown Primary Head and Neck Cancer
Official Title
The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of Neck Nodes With an Unknown Primary Malignancy.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Tom Baker Cancer Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
unknown primary, head and neck cancer, squamous cell carcinoma, Unknown primary head and neck cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PET/CT
Intervention Description
PET/CT is being performed on all patients in the study.
Primary Outcome Measure Information:
Title
proportion of patients where PET/CT resulted in a change in diagnosis
Time Frame
2 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
PET/CT: Role in Detecting Unknown Primary Head and Neck Cancer
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