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Completed

NCT Number: NCT03058705

Near Infrared Fluorescence Imaging for Bladder Cancer Detection

The primary outcome of this study is to determine the minimal dwell time needed for adequate detection of hexaminolevinulate HCL avid tumors using protoporphyrin IX (PpIX) near infrared fluorescence (NIRF).

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of bladder mass on office cystoscopy suspicious for malignancy, either newly diagnosed or a recurrent tumor.
  • Planned transurethral resection of bladder tumor in the operating room.
  • Ability to give informed consent.
  • Willing to spend time for the study
  • Men or women (age 18 or older)
  • Any racial or ethnic origin

Exclusion criteria

  • Pregnancy
  • Nursing mother
  • Diagnosis of porphyria
  • Gross hematuria
  • BCG immunotherapy or intravesical chemotherapy within the past 90 days
  • Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid

Treatment and study plan

Hexaminolevulinate HCL

Drug

Intravesical instillation of 100 mg hexaminolevulinate HCL will be performed via foley catheter at the initiation of the procedure. Although NIRF is more sensitive than bluelight cystoscopy, the current FDA approved dose will be used. Hexaminolevulinate has a favorable safety profile at this dose.

Near Infrared Fluorescence (NIRF)

Device

NIRF is a highly sensitive multi-spectral imaging modality that speeds the detection of bladder cancer fluorescence after infusion of hexaminolevinulate.

Primary outcomes

  1. Minimal Dwell Time

    Time frame: Day 1

    The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).

Sponsors and collaborators

Lead sponsor

Edward Messing

Other

Collaborators

  • Imagin Medical

Registry information

Official study title

Pilot Study: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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