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Near Infrared Fluorescence Imaging for Bladder Cancer Detection

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ClinicalTrials.gov Identifier: NCT03058705

Recruitment Status : Recruiting

First Posted : February 23, 2017

Last Update Posted : November 30, 2017

See Contacts and Locations

Sponsor:

Collaborator:

Imagin Medical

Information provided by (Responsible Party):

Edward Messing, University of Rochester

Study Description

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


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	10 participants
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
Estimated Primary Completion Date :	December 1, 2018
Estimated Study Completion Date :	December 1, 2018

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Bladder cancer

MedlinePlus related topics: Bladder Cancer

Drug Information available for: Hexaminolevulinate

U.S. FDA Resources

Arms and Interventions

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.

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

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).

Eligibility Criteria

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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

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

Locations


United States, New York
University of Rochester Medical Center	Recruiting
Rochester, New York, United States, 14642
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 Posted:	February 23, 2017 Key Record Dates
Last Update Posted:	November 30, 2017
Last Verified:	November 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:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		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

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