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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852252
• Other study ID #: 822933
• Status: Completed
• Start date: July 2016
• Est. completion date: February 2020

Study information

• Verified date: June 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Gastric Cancer
• Stomach Neoplasms
• Urinary Bladder Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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