Trial Outcomes & Findings for Near Infrared Fluorescence Imaging for Bladder Cancer Detection (NCT NCT03058705)
NCT ID: NCT03058705
Last Updated: 2019-08-19
Results Overview
The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Day 1
Results posted on
2019-08-19
Participant Flow
Participant milestones
| Measure |
Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
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 Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
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 Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Near Infrared Fluorescence Imaging for Bladder Cancer Detection
Baseline characteristics by cohort
| Measure |
Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
n=10 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Dwell time was not collected on any participant due to failure to visual fluorescence in the subjects.
The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).
Outcome measures
Outcome data not reported
Adverse Events
Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place