Detection of Cervical Lymph Node Metastases With a High-Resolution Positron Emission Tomography (PET) Imaging System

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT01030497
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/CT.

Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.

Detailed Description

If you agree to take part in this study, right after your already scheduled routine PET/CT scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine PET/CT scan was just performed.

You will then sit in a chair as a study staff member positions the PEMFlex Solo II on either side of the part of the neck that has, or is suspected to have cancer. It will take about 20 minutes to set up the PEMFlex Solo II and take the PET scan images.

Length of Study:

After the PET scan images have been taken using the PEMFlex Solo II, your participation in this study will be over.

This is an investigational study. The PEMFlex Solo II is commercially available for PET scan imaging of the breast. Using the PEMFlex Solo II for imaging any other parts of the body is investigational.

Up to 10 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. A signed informed consent.
2. Known or suspected primary cancer of the upper aerodigestive tract, which may be determined by biopsy, physical examination- including upper endoscopy or noninvasive imaging studies including CT, MR, ultrasound, or prior PET.
3. Known or suspected metastatic disease to cervical lymph nodes based on physical examination, imaging studies or biopsy.
4. Scheduled for routine clinical imaging at the ACB PET/CT facility.
5. Participant must be at least 18 years of age.

Exclusion Criteria

1. Prior treatment (chemotherapy, radiotherapy) for cancer of the upper aerodigestive tract.
2. Prior biopsy procedures, including resection of the primary cancer, will not exclude the patient from participation.
3. Uncontrolled blood glucose levels (>200 mg/dl).
4. Patient is unable to comprehend the requirements of the study.
5. Patient is unable to undergo scanning of the neck with the PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images.	20 minutes for imaging using PEMFlex Solo II, within ± 30 days of standard PET/CT imaging

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States