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

May 13, 2014 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with known or suspected primary cancer of the upper aerodigestive tract or metastatic disease to cervical lymph nodes, over 18 years of age, and scheduled for routine clinical imaging at the PET/CT facility.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
20 minutes for imaging using PEMFlex Solo II, within ± 30 days of standard PET/CT imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Study Chair: Eric Rohren, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (Estimate)

December 11, 2009

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0477

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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