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CompletedNCT02852252Updated Jun 18, 2021

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

An observational study in Bladder Cancer and Gastric Cancer, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-18.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
291
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Bladder Cancer
  • Gastric Cancer
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In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 291 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
291 participants (actual)
Target follow-up
30 Days
Patient registry
Yes

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.

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What researchers measure

Primary outcomes

  1. Tissue to Background Ratio

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

    Time frame: 2 years

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Study locations

1 site
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02852252
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Aug 2, 2016
Start date
Jul 2016
Primary completion
Feb 2020
Completion
Feb 2020
Last update
Jun 18, 2021

Study contacts

Sunil Singhal
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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