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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02852252
• Collaborator: (none)
• Enrollment: 291
• Location: 1
• Actual Duration (Months): 43
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer; Gastric Cancer	Drug: OTL38; Drug: ICG

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 291 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry Optional Sub-Study I: ICG Optional Sub-Study II: OTL38
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Feb 1, 2020
• Actual Study Completion Date: Feb 1, 2020

Outcome Measures

Primary Outcome Measures

1. Tissue to Background Ratio [2 years]

   Enhance ability to detect malignant tissues in situ and ex vivo.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Sunil Singhal, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02852252
• Other Study ID Numbers: 822933
• First Posted: Aug 2, 2016
• Last Update Posted: Jun 18, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Jun 18, 2021