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Near Infrared Fluorescence Imaging for Bladder Cancer Detection

NCT03058705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-08-19

Study results available
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Summary

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).

Conditions

Interventions

DRUG

Hexaminolevulinate HCL

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.

DEVICE

Near Infrared Fluorescence (NIRF)

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

Sponsors & Collaborators

  • Imagin Medical

    collaborator UNKNOWN

  • Edward Messing

    lead OTHER

Principal Investigators

  • Edward M Messing, MD · University of Rochester

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2018-07-25
Completion
2018-07-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03058705 on ClinicalTrials.gov