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Near Infrared Fluorescence Imaging for Bladder Cancer Detection

E

Edward Messing

Status

Completed

Conditions

Bladder Cancer

Treatments

Device: Near Infrared Fluorescence (NIRF)
Drug: Hexaminolevulinate HCL

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)
Experimental group
Description:
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.
Treatment:
Device: Near Infrared Fluorescence (NIRF)
Drug: Hexaminolevulinate HCL

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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