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

Not Applicable

Withdrawn

• Conditions: Head and Neck Neoplasms
• Interventions: Device: Imaging Beta Probe (IBP)

• Registration Number: NCT03561324
• Lead Sponsor: University of Arkansas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-19
• Study Start: 2018-06-20
• Status Verified: 2020-01
• Primary Completion: 2020-01-22
• Study Completion: 2020-01-22
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of IntraOperative Imaging Probe	Imaging Beta Probe (IBP)	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States