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Trial record 1 of 1 for:    imagin medical
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Near Infrared Fluorescence Imaging for Bladder Cancer Detection

This study is not yet open for participant recruitment.
Verified July 2017 by Edward Messing, University of Rochester
Sponsor:
ClinicalTrials.gov Identifier:
NCT03058705
First Posted: February 23, 2017
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Imagin Medical
Information provided by (Responsible Party):
Edward Messing, University of Rochester
  Purpose
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).

Condition Intervention
Bladder Cancer Drug: Hexaminolevulinate HCL Device: Near Infrared Fluorescence (NIRF)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pilot Study: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Edward Messing, University of Rochester:

Primary Outcome Measures:
  • Minimal Dwell Time [ Time Frame: Day 1 ]
    The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).


Estimated Enrollment: 10
Anticipated Study Start Date: October 1, 2017
Estimated Study Completion Date: December 1, 2018
Estimated Primary Completion Date: October 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058705


Contacts
Contact: Edward M Messing, MD 585-275-0998 edward_messing@urmc.rochester.edu
Contact: Scott Quarrier, MD scott_quarrier@urmc.rochester.edu

Sponsors and Collaborators
Edward Messing
Imagin Medical
Investigators
Principal Investigator: Edward M Messing, MD University of Rochester
  More Information

Responsible Party: Edward Messing, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT03058705     History of Changes
Other Study ID Numbers: 66682
First Submitted: February 16, 2017
First Posted: February 23, 2017
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents