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

NCT03561324 | Withdrawn FDA Device

• 1 other identifier: 217729
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Use of IntraOperative Imaging Probe

EXPERIMENTAL

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)

Interventions

Imaging Beta Probe (IBP) DEVICE

Using IBP for imaging of PET positive lymph nodes

Use of IntraOperative Imaging Probe

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, 18- to 90-years old.
• Positive for PET positive disease in the neck.

You may not qualify if:

• Pregnant women (all women of child bearing potential will have undergone pregnancy testing as standard of care)
• Nursing or lactating women

Sponsors & Collaborators

• University of Arkansas: lead
• Radiation Monitoring Devices, Inc.: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Deanne L King, MD

  501-686-5140

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 19, 2018
• Study Start: June 20, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)