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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02852252

Enrollment

291

Registered

2016-08-02

Start date

2016-07-31

Completion date

2020-02-29

Last updated

2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Gastric Cancer

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.

Interventions

DRUGOTL38

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

DRUGICG

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Tissue to Background Ratio	2 years	Enhance ability to detect malignant tissues in situ and ex vivo.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026