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NCT03561324 Clinical Trial

Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager

Head and Neck Neoplasms Clinical Trial

Official title:
Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03561324
Other study ID # 217729
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 20, 2018
Est. completion date January 22, 2020

Study information
Verified date January 2020
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 22, 2020
Est. primary completion date January 22, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Imaging Beta Probe (IBP)
Using IBP for imaging of PET positive lymph nodes

Locations
Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (2)
Lead Sponsor Collaborator
University of Arkansas Radiation Monitoring Devices, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of PET positive disease Localization between imaging modalities will be compared with respect to: detection (y/n) and side of localization (r/l). Day 1
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