Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
28 participants
INTERVENTIONAL
2017-09-14
2019-04-15
Brief Summary
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Regarding parathyroid identification, this technology has the potential to identify these very small glands during procedures they are at risk. These glands are not only at risk of inadvertent removal if not adequately identified, but may also be at risk if devascularized by manipulation during the surgical procedure. Therefore, early and accurate identification may decrease the rate of temporary and permanent hypoparathyroidism and hypocalcemia. This is not only an issue during thyroid and parathyroid surgery, but during laryngectomy surgery where the anatomic region these glands are located are often resected to remove at risk lymph nodes from cancer spread. Therefore, identifying these glands may help preserve parathyroid function in this patient population as well.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Arm 1: Goggle Imaging
-Patient will then be taken to the operating room for this surgical procedure. Prior to starting the operation, the patient will undergo injection of ICG around the tumor per standard techniques while in the operating room. Those undergoing intraoperative visualization of parathyroid glands will not have any administration of ICG as these glands autofluoresce. Patients will then undergo the standard SLN biopsy procedure (those undergoing parathyroid visualization will not undergo this). The surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance or parathryroid visualization. After this is performed, the goggle system will be removed and the procedure will be completed per normal.
Hands-free goggle system
-Manufactured at Washington University
Interventions
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Hands-free goggle system
-Manufactured at Washington University
Eligibility Criteria
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Inclusion Criteria
* Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma. Patients with central neck pathology including thyroid neoplasms, parathyroid neoplasms, and laryngeal neoplasms undergoing surgical resection.
* Candidates for sentinel lymph node biopsy or central neck surgery
* Newly diagnosed with clinically node negative head and neck cancer being staged with sentinel lymph node biopsy.
* Not pregnant or breast feeding.
* Able to understand and willing to sign an IRB-approved written informed consent document.
* Able to understand written or spoken English.
Exclusion Criteria
* Pregnant or breast feeding
* Do not fit age criteria
* Prisoners
* Unable to provide written consent
* Contraindications for surgery
\*Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the head and neck, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Receiving any other investigational agents
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Ryan S Jackson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201708068
Identifier Type: -
Identifier Source: org_study_id
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