Detection of Cervical Lymph Node Metastases With a High-Resolution Positron Emission Tomography (PET) Imaging System
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Phase: N/A
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Eric Rohren, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center
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.
Clinical Details
Official 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
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.).
Locations and Contacts
University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
UT MD Anderson Cancer Center website
Starting date: December 2009
Last updated: May 13, 2014
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