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

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.

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Device: Imaging Beta Probe (IBP)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Use of IntraOperative Imaging Probe; The sterilized (Imaging Beta Probe) IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins.	Device: Imaging Beta Probe (IBP); Using IBP for imaging of PET positive lymph nodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: Radiation Monitoring Devices, Inc.
• Investigators: Study Director: Deanne L King, MD, 501-686-5140

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2018
• Primary Completion (ACTUAL): January 22, 2020
• Study Completion (ACTUAL): January 22, 2020

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (ACTUAL): June 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 217729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No