Head and Neck Neoplasms
Conditions
Brief summary
This study is a prospective collection of data utilizing the Imaging Beta Probe (IBP) in patients with positron emission tomography (PET) positive disease. A pilot clinical study involving 5 patients will be conducted using the IBP. The sterilized IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. The outcome of each of these studies will be documented and used to demonstrate clinical benefits of the new probe. The investigators will correlate the images from the probe of the Fludeoxyglucose (18FDG) positive tissue, both in-vivo and ex-vivo after dissection, with the previously performed PET scan and with the routine pathology results obtained on the surgical specimens.The experimental imaging modality studied in this protocol will be compared to clinically utilized modalities of ultrasound and PET/ CT. Localization between imaging modalities will be compared with respect to: detection and side of localization.
Interventions
DEVICEImaging Beta Probe (IBP)
Using IBP for imaging of PET positive lymph nodes
Sponsors
Radiation Monitoring Devices, Inc.
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Men and women, 18- to 90-years old. * Positive for PET positive disease in the neck.
Exclusion criteria
* Pregnant women (all women of child bearing potential will have undergone pregnancy testing as standard of care) * Nursing or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of PET positive disease | Day 1 | Localization between imaging modalities will be compared with respect to: detection (y/n) and side of localization (r/l). |
Countries
United States
Outcome results
None listed