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OpenTrials
Completed

NCT Number: NCT02852252

Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry

The study objective is to collect prospective data on cancer patients who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

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Key information

About this study

Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients >/= 18 years of age.
  • 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

  • Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery.
  • Vulnerable patient population.

Treatment and study plan

OTL38

Drug

Patients will be given imaging agent 2-3 hours before surgery to assist in imaging.

ICG

Drug

Patients will be given imaging agent 24 hours before surgery to assist in imaging.

Primary outcomes

  1. Tissue to Background Ratio

    Time frame: 2 years

    Enhance ability to detect malignant tissues in situ and ex vivo.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry Optional Sub-Study I: ICG Optional Sub-Study II: OTL38

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2016
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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