A Phase 3 interventional study of Hexaminolevulinate hydrochloride and KARL STORZ D-Light C PDD Flexible Videoscope System in Bladder Cancer, sponsored by Photocure. Completed at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-02.
Sponsored by Photocure · Phase 3, Interventional, and Diagnostic
The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.
1,649 studies on the registry are indexed under Urinary Bladder Neoplasms; 427 are open to participants now.
This study's enrollment of 304 is above the median of 60 across 1,183 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Photocure is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
History of one or more of the following:
Exclusion Criteria:
In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure) All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours. Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System
Drug: Hexaminolevulinate hydrochloride · Device: KARL STORZ D-Light C PDD Flexible Videoscope System
Instillation in bladder
Also known as: Cysview
Cystoscopy procedure
Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy
In the subsection of patients with histologically confirmed malignancy, the proportion of patients detected only by the use of blue light cystoscopy with Cysview is measured.
Time frame: At time of cystoscopy procedure
Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination
Time frame: At time of cystoscopy procedure
Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy
In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.
Time frame: At time of cystoscopy procedure
| Milestone | Cysview Arm |
|---|---|
| Started | 304 |
| Completed | 304 |
| Not completed | 0 |
In the subsection of patients with histologically confirmed malignancy, the proportion of patients detected only by the use of blue light cystoscopy with Cysview is measured.
| Participants | Cysview Arm |
|---|---|
| Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy | 13 |
| Participants | Surveillance Examination | Surveillance + OR Examination |
|---|---|---|
| Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination | 6 | 3 |
In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.
| Participants | Cysview Arm |
|---|---|
| Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy | 9 |
Collected over The period of observation in the surveillance examination was defined as the period from instillation of Cysview until the patient left the hospital. The period of observation in the operating room examination was defined as the period from instillation of Cysview until hospital discharge or for a maximum of 24 hours after the instillation if the patient was still at the hospital.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cysview Arm | 0/304 (0%) | 1/304 (0.3%) | 17/304 (5.6%) |
| Event | Cysview Arm |
|---|---|
| Aspiration, Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 1/304 |
| Event | Cysview Arm |
|---|---|
| Bladder discomfort, Bladder pain, Bladder spasm, Dysuria, Urethral pain, Urinary bladder hemorrhageRenal and urinary disorders | 12/304 |
| Procedural painInjury, poisoning and procedural complications | 2/304 |
| Pain, PyrexiaGeneral disorders | 2/304 |
| Dermatitis contact, erythema, priuritusSkin and subcutaneous tissue disorders | 2/304 |
| NauseaGastrointestinal disorders | 1/304 |
This is a single-arm trial. All participants received the same intervention. All enrolled participants received Cysview and an examination in the office and were referred to a second procedure in the operating room if medically indicated in the first examination. Baseline characteristics are reported for all enrolled participants.
| Age, Continuous(years) | Cysview Arm |
|---|---|
| Mean | 69.0 ± 10.4 |
| Sex: Female, Male(Participants) | Cysview Arm |
|---|---|
| Female | 62 |
| Male | 242 |
| Ethnicity (NIH/OMB)(Participants) | Cysview Arm |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 296 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Cysview Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 20 |
| White | 272 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Number of Previous Recurrences(number of previous recurrences) | Cysview Arm |
|---|---|
| Mean | 1.7 ± 2.0 |
| History of CIS(Participants) | Cysview Arm |
|---|---|
| Count of participants | 127 |
| History of High Grade (Grade 2 or 3) Ta or T1(Participants) | Cysview Arm |
|---|---|
| Count of participants | 222 |
| Patients Treated with intravesical chemotherapy(Participants) | Cysview Arm |
|---|---|
| Count of participants | 114 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — IPD will not be shared with other researchers
Ran from Oct 2015 to primary completion in Apr 2017, 18 months.
Results were first posted in Jul 2018, 1 year 2 months after primary completion.
Of 72 phase 3 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 92. This study's 18 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hexaminolevulinate hydrochloride