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Clinical Trials/NCT03561324
NCT03561324
Withdrawn
Not Applicable

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

University of Arkansas1 site in 1 countryJune 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Neoplasms
Sponsor
University of Arkansas
Locations
1
Primary Endpoint
Detection of PET positive disease
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 20, 2018
End Date
January 22, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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).

Study Sites (1)

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