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

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

INTRODUCTION

  • Org Study ID: 822933
  • Secondary ID: N/A
  • NCT ID: NCT02852252
  • Sponsor: University of Pennsylvania

BRIEF SUMMARY

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.

DETAILED DESCRIPTION

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.

  • Overall Status
    Completed
  • Start Date
    July, 2016
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Tissue to Background Ratio

Primary Outcome 1 - Timeframe: 2 years

CONDITION

  • Bladder Cancer
  • Gastric Cancer

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Sunil Singhal

Role: Principal Investigator

Affiliation: University of Pennsylvania

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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