Near Infrared Fluorescence Imaging for Bladder Cancer Detection

Part of paid clinical trials in Rochester, New York.

Sponsor
Edward Messing
Study ID
NCT03058705
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Nov 28, 2017
Status verified
Aug 2019
Primary completion
Jul 25, 2018
Completion
Jul 25, 2018

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)
    During the transurethral resection of the bladder procedure, the bladder will initially be examined in a systematic meridian fashion. Suspicious tumors identified by white light only, NIRF only, and both will be identified. If intense fluorescence is observed in the initial patient(s) at 10 min, dwell duration will be reduced to 5 min for the next patient(s); if abundant fluorescence is detected there as well, dwell duration will be shortened again to 2.5 min. At least three patients will be studied at each duration to document intense fluorescence before proceeding to shorter instillation durations in subsequent patients.

Primary Outcome Measure

Minimal Dwell Time [ Time Frame: Day 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14642-

Find similar trials in Rochester, NY

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
University of Rochester Medical Center· Rochester, NY

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