An observational study in Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-14.
Sponsored by M.D. Anderson Cancer Center · Observational
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.
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.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's enrollment of 1 is below the median of 100 across 453 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
The record gives a start of Dec 2009 and a primary completion of May 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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