Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry
NCT ID: NCT02852252
Last Updated: 2021-06-18
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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COMPLETED
291 participants
OBSERVATIONAL
2016-07-31
2020-02-29
Brief Summary
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Detailed Description
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In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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OTL38
Patients will be given imaging agent 2-3 hours before surgery to assist in imaging.
ICG
Patients will be given imaging agent 24 hours before surgery to assist in imaging.
Eligibility Criteria
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Inclusion Criteria
* Patients presenting with esophagogastric or bladder cancer.
* Good operative candidate as determined by the treating physician and/or multidisciplinary team.
* Subject capable of giving informed consent and participating in the process of consent.
Exclusion Criteria
* Vulnerable patient population.
18 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Sunil Singhal
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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822933
Identifier Type: -
Identifier Source: org_study_id
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