Optional Sub-study to Intraoperative Imaging With ICG Registry

Completed

• Conditions: Lung, Prostate, Breast, Colon, Pancreatic, Renal, Bladder,Thyroid, Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut) Cancer; Cancer of Neuro-onc, Parathyroid, Desmoid Tumors, Melanoma Cancer; Cancer of the Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut), Sarcoma Cancer

• Registration Number: NCT02651246
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

The primary goal of this optional sub-study is to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed.

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

• Adult patients >= 18 years of age
• Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence.
• 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 populations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of tumor recurrence	2 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States