Back to resultsIntraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager
Primary Purpose
Head and Neck Neoplasms
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imaging Beta Probe (IBP)
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Neoplasms
Eligibility Criteria
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
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Use of IntraOperative Imaging Probe
Arm Description
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.
Outcomes
Primary Outcome Measures
Detection of PET positive disease
Localization between imaging modalities will be compared with respect to: detection (y/n) and side of localization (r/l).
Secondary Outcome Measures
Full Information
NCT ID
NCT03561324
First Posted
May 31, 2018
Last Updated
January 27, 2020
Sponsor
University of Arkansas
Collaborators
Radiation Monitoring Devices, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03561324
Brief Title
Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager
Official Title
Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI leaving institution/no funding
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Radiation Monitoring Devices, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Use of IntraOperative Imaging Probe
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Imaging Beta Probe (IBP)
Intervention Description
Using IBP for imaging of PET positive lymph nodes
Primary Outcome Measure Information:
Title
Detection of PET positive disease
Description
Localization between imaging modalities will be compared with respect to: detection (y/n) and side of localization (r/l).
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deanne L King, MD
Organizational Affiliation
501-686-5140
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager
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