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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 22, 2020

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Detection of PET positive disease
    • Time Frame: Day 1
    • Localization between imaging modalities will be compared with respect to: detection (y/n) and side of localization (r/l).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Arkansas
  • Collaborator
    • Radiation Monitoring Devices, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Deanne L King, MD, Study Director, 501-686-5140

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.