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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

Study Groups

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A

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.

Group Type EXPERIMENTAL

PET/CT

Intervention Type OTHER

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

Interventions

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PET/CT

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No