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Trial record 1 of 2 for:    imagin medical
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Near Infrared Fluorescence Imaging for Bladder Cancer Detection

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03058705
Recruitment Status : Completed
First Posted : February 23, 2017
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
Imagin Medical
Information provided by (Responsible Party):
Edward Messing, University of Rochester

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Hexaminolevulinate HCL Device: Near Infrared Fluorescence (NIRF) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : July 25, 2018
Actual Study Completion Date : July 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
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.


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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
Edward Messing
Imagin Medical
Investigators
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Principal Investigator: Edward M Messing, MD University of Rochester
  Study Documents (Full-Text)

Documents provided by Edward Messing, University of Rochester:
Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2018
Informed Consent Form  [PDF] March 1, 2018

More Information
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Responsible Party: Edward Messing, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT03058705    
Other Study ID Numbers: 66682
First Posted: February 23, 2017    Key Record Dates
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases