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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A signed informed consent.
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.
Known or suspected metastatic disease to cervical lymph nodes based on physical examination, imaging studies or biopsy.
Scheduled for routine clinical imaging at the ACB PET/CT facility.
Participant must be at least 18 years of age.

Exclusion criteria

Prior treatment (chemotherapy, radiotherapy) for cancer of the upper aerodigestive tract.
Prior biopsy procedures, including resection of the primary cancer, will not exclude the patient from participation.
Uncontrolled blood glucose levels (>200 mg/dl).
Patient is unable to comprehend the requirements of the study.
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.).

Treatment and study plan

Primary outcomes

Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images.

Time frame: 20 minutes for imaging using PEMFlex Solo II, within ± 30 days of standard PET/CT imaging

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Feasibility Study for Detection of Cervical Lymph Node Metastases With a High-Resolution PET Imaging System in Patients With Known or Suspected Cancers of the Upper Aerodigestive Tract

Important dates

Study start: 2009
Primary completion: 2014
First posted: Dec 11, 2009
Registry last updated: May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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