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NCT03561324

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

Withdrawn NA Last updated 29 January 2020
What this trial tests

NA trial testing Imaging Beta Probe (IBP) in Head and Neck Neoplasms. Withdrawn.

Timeline
20 June 2018
Primary endpoint
22 January 2020
22 January 2020

Quick facts

Lead sponsorUniversity of Arkansas
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Start date20 June 2018
Primary completion22 January 2020
Estimated completion22 January 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Arkansas

Who can join

Adults 18 to 90, any sex, with Head and Neck Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Head and Neck Neoplasms

Currently open trials in the same condition.

Other University of Arkansas trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03561324.

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