Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    imagin medical
Previous Study | Return to List | Next Study

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 Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Device Feasibility
Condition Bladder Cancer
Interventions Drug: Hexaminolevulinate HCL
Device: Near Infrared Fluorescence (NIRF)
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
Hide Arm/Group Description

Patients with possible bladder cancer to be evaluated using near infrared fluorescence imaging (NIRF) device.

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.

Period Title: Overall Study
Started 10
Completed 6
Not Completed 4
Reason Not Completed
Withdrawal by Subject             2
Physician Decision             2
Arm/Group Title Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
Hide Arm/Group Description

Patients with possible bladder cancer to be evaluated using near infrared fluorescence imaging (NIRF) device.

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.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
10
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  10.0%
White
9
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Minimal Dwell Time
Hide Description The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Dwell time was not collected on any participant due to failure to visual fluorescence in the subjects.
Arm/Group Title Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
Hide Arm/Group Description:

Patients with possible bladder cancer to be evaluated using near infrared fluorescence imaging (NIRF) device.

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
Hide Arm/Group Description

Patients with possible bladder cancer to be evaluated using near infrared fluorescence imaging (NIRF) device.

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.

All-Cause Mortality
Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Edward Messing, MD
Organization: University of Rochester
Phone: 585-275-0998
Responsible Party: Edward Messing, 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
Results First Submitted: July 1, 2019
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019