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NCT00656760 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00656760
Other study ID # UCENT0001
Secondary ID
Status Completed
Phase N/A
First received April 7, 2008
Last updated May 17, 2016
Start date July 2007
Est. completion date March 2011

Study information
Verified date May 2016
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta

Sponsors (2)
Lead Sponsor Collaborator
University of Calgary Tom Baker Cancer Centre

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary proportion of patients where PET/CT resulted in a change in diagnosis 2 weeks after surgery No
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