Little Rock, Arkansas 72205

  • Head and Neck Neoplasms

Purpose:

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.


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


Study is Available At:


Original ID:

217729


NCT ID:

NCT03561324


Secondary ID:


Study Acronym:


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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Arkansas


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:

PI leaving institution/no funding


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Deanne L King, MD
Study Director
501-686-5140

Study Dates

Start Date:June 20, 2018
Completion Date:January 22, 2020
Completion Type:Actual
Primary Completion Date:January 22, 2020
Primary Completion Type:Actual
Verification Date:January 2020
Last Changed Date:January 27, 2020
First Received Date:May 31, 2018

Study Outcomes

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

Study Interventions

Intervention Type:Device
Name:Imaging Beta Probe (IBP)
Description:Using IBP for imaging of PET positive lymph nodes
Arm Name:Use of IntraOperative Imaging Probe

Study Arms

Study Arm Type:Experimental
Arm Name:Use of IntraOperative Imaging Probe
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Arkansas
Agency Class:Other
Agency Type:Collaborator
Agency Name:Radiation Monitoring Devices, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.