CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Hexaminolevulinate HCL +1 moredrug
Likely dose
Hexaminolevulinate HCL 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03058705
NCT03058705N/ACompleted
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Pilot Study: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer

Edward Messing·interventional·Posted Feb 23, 2017·Updated Aug 19, 2019

In Brief

A clinical study evaluating Hexaminolevulinate HCL and Near Infrared Fluorescence (NIRF) for Bladder Cancer. Completed, enrolled 10 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsImagin Medical

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartNov 28, 2017
Primary CompletionJul 25, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.4 years ago

Interventions

Hexaminolevulinate HCLdrug

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.