Bladder Cancer
Conditions
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).
Interventions
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.
DEVICENear Infrared Fluorescence (NIRF)
NIRF is a highly sensitive multi-spectral imaging modality that speeds the detection of bladder cancer fluorescence after infusion of hexaminolevinulate.
Sponsors
Imagin Medical
Edward Messing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal Dwell Time | Day 1 | The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Hexaminolevinulate HCL With Near Infrared Fluorescence (NIRF) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Minimal Dwell Time
The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).
Time frame: Day 1
Population: Dwell time was not collected on any participant due to failure to visual fluorescence in the subjects.