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

NCT02852252 | Completed DMC

• 1 other identifier: 822933
• Study Type: observational
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Tissue to Background Ratio

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

  2 years

Interventions

OTL38 DRUG

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

ICG DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a high clinical suspicion of cancer, scheduled to undergo surgery.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery.
• Vulnerable patient population.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Stomach Neoplasms

Interventions

Pafolacianine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Sunil Singhal

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 2, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

US (1)