Effectiveness in Head and Neck Cancer Detection Using Positron Emission Tomography (PET) Insert Device

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

Official title: Effectiveness in Head and Neck Cancer Detection Using PET Insert Device

Status Withdrawn

Clinical Trial Summary

We have developed a prototype PET insert device that can be integrated into a clinical PET/computed tomography (CT) scanner to improve its image resolution to approximately 2.5 mm in all 3 dimensions within a reduced imaging field of view (FOV). This zoom-in imaging capability provides 6-fold improvement in volumetric image resolution over the current state-of-the-art clinical PET scanner, offering a tremendous opportunity for cancer imaging applications, in particular for those cases where a lymph node involvement will drastically alter the patient management plan. Accurate diagnosis and staging of head-and-neck cancer is known to be challenging because of the complex anatomy and large number of lymph nodes involved in this region. As a result, head and neck cancer imaging is an ideal candidate for evaluating the clinical usefulness of this novel imaging device.

Clinical Trial Description

In this project, we propose to conduct an exploratory clinical trial to investigate the effectiveness of this novel imaging device in detecting small lesions and lymph node involvements in the head and neck region, and compare its results to those obtained from a clinical PET/CT scanner. More specifically, we propose to (1) recruit 5 patients who have confirmed head and neck cancer and are scheduled to receive a whole-body PET/CT scan followed by surgical operation to remove the primary tumor and the regional lymph nodes. These patients will be imaged by a state-of-the-art PET/CT scanner using the standard whole-body PET/CT imaging protocol as standard of care for initial staging. On another day, following consent to participate in this research protocol, A patient will undergo images of the head and neck region using the same type scanner with and without our novel PET insert device attached; (2) The images obtained from the PET insert device will be reviewed by experienced nuclear medicine physicians to identify the extent of lymph node involvement. The PET insert images will be compared to the standard clinical PET/CT images. A detailed image obtained for purposes of research, centered at the level of the head and neck, acquired for approximately 3 times the length of time the standard clinical image is obtained for will also be compared to the PET insert image. Images will also be compared to the pathology report of the surgically removed specimen. (3) Estimate the performance of lesion detection for different sizes of tumors using the standard PET/CT scanner as well as the PET insert device. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of the Head and Neck

• NCT number: NCT01133262
• Study type: Observational
• Source: Washington University School of Medicine
• Status: Withdrawn
• Phase: N/A
• Start date: June 2010
• Completion date: December 2011