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

University of Pennsylvania

Status: Completed

Conditions: Bladder Cancer; Gastric Cancer

Treatments: Drug: OTL38; Drug: ICG

Study type: Observational

Funder types: Other

Identifiers

NCT02852252

822933

Details and patient eligibility

About

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.

Full 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.

Enrollment: 291 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.