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Urinary Bladder Neoplasms

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Female Urogenital Diseases and Pregnancy Complications

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All Drugs and Chemicals

Dermatologic Agents

Aminolevulinic Acid

Photosensitizing Agents

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

Hexaminolevulinate hydrochloride

KARL STORZ D-Light C PDD Flexible Videoscope System

Mark Schoenberg, MD

J. Stephen Jones, MD

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.

This is a prospective, open, comparative, within-patient controlled Phase 3 multicenter study in patients with bladder cancer. There is a maximum of three study visits for an enrolled patient:

Visit 1: Screening visit Visit 2: Surveillance cystoscopy in white light (WL) followed by blue light (BL) Visit 3: Operating room (OR) cystoscopy in WL followed by BL for patients with suspicion of recurrence after surveillance cystoscopy.

Cystoscopy in WL followed by BL is performed in all patients after Cysview instillation. Only patients with suspicious lesions at Visit 2 continue to a second cystoscopy in WL followed by BL at Visit 3.

A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting

A Prospective, Open, Comparative, Within Patient Controlled Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients With Bladder Cancer

IPD will not be shared with other researchers

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.

In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.

KARL STORZ Endoscopy-America, Inc.

Photocure

Cysview Arm

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Number of Previous Recurrences

History of CIS

Under the American Joint Committee on Cancer (AJCC) staging system, also known as the Tumor-Node-Metastases (TNM), pathological stages of NMIBC includes the following: (1) papillary tumors confined to the epithelial mucosa (stage Ta), (2) tumors invading the subepithelial tissue (i.e., lamina propria; T1), and (3) carcinoma in situ. The 1973 World Health Organization (WHO) classification was the widely accepted format for grading bladder neoplasia. The 1973 version designated tumors as either papilloma, grade 1, 2, or 3, whereas the 2004 revision designated tumors as 'low' or 'high' grade.

History of High Grade (Grade 2 or 3) Ta or T1

Patients Treated with intravesical chemotherapy

Patients with Previous Treatment with BCG Immunotherapy

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.

Dr. J. Stephen Jones

The proportion of patients with malignancy detected only with BLC with Cysview was to be analyzed using an exact one-sided test for a single proportion based on the cumulative binomial distribution with a significance level of 2.5%.

Null hypothesis: Malignancy is detected with BL only in 0.5% or less of the patients

Patients with histologically confirmed malignancy

Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy

Patients who received Cysview instillation in the surveillance examination.

Surveillance Examination

Patients who received a Cysview instillation in both surveillance and OR examinations.

Surveillance + OR Examination

This is a within patient control trial, where the white light (WL) cystoscopy was the comparator. Enrolled participants received a WL and blue light (BL) surveillance examination after Cysview instillation. Operating room (OR) cystoscopy in WL and BL was performed for patients with suspicion of recurrence after surveillance cystoscopy.

Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination

The proportion of patients with one or more CIS lesions detected with BL and none with WL was to be evaluated using an exact binomial test for single proportion with a significance level of 2.5% (one-sided).

Null hypothesis: One or more CIS lesions are detected with BLC with Cysview and none with WL in less than or equal to 0.1% of the patients.

Number of patients with histologically confirmed CIS

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

Overall Study

Bladder cancer patients who have undergone Blue light cystoscopy with Hexaminolevulinate hydrochloride (Cysview®) 100mg in 50 milliliters (mL) reconstituted solution instilled intravesically into bladder prior to cystoscopy in operating room (OR). Retention time: 1-3 hours. The Karl Storz D-Light C Photodynamic Diagnostic (PDD) system is used for the cystoscopy procedure at the OR examination.

Hexaminolevulinate hydrochloride (HCL)

Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

Chad McKee, PhD

Charles Peyton, MD

Mark Tyson, MD, MPH

Ileana Aldana

Sia Daneshmand, MD

Anne Schuckman, MD

Mihir Desai, MD

Hooman Djaladat, MD

Gerhard Fuchs, MD

Virinder Bhardwaj, MD

Karim Chamie, MD

Dorothy Trivedi

Joseph Liao, MD

James Crotty, MD

John Leppert, MD

John Lavelle, MD

Sima Porten, MD, MPH

Armine Smith, MD

Vikram Narayan, MD

Shreyas Joshi, MD

Lehman G Jennifer, RN, CCRP

Hristos Z Kaimakliotis, MD

Jane Ledesma

John Taylor, MD, MS

Jeffrey Holzbeierlein, MD, FACS

Morgan De Carli

Max Kates, MD

Maressa Twedt

Hamed Ahmadi, MD

Subodh Regmi, MD

Gary Steinberg, MD

Kamal Pohar, MD

Megan Merrill, DO

Ahmad Shabsigh, MD

David Sharp, MD

Rachel Link, CCRP

Kamal S Pohar, MD

Nicol Brandon

T. Brian Willard, MD

David Lamb, MD

Scott Sweazy, MD

Keith Birghtbill, MD

Michael Stotzer, MD

Yair Lotan, MD

Aditya Bagrodia, MD

Ashley Jones, BS, CCRP

Jennifer Taylor, MD, MPH

Jeffrey Jones, MD

Sidney Worsham, MD

John Gore, MD

Siamak Daneshmand, MD

Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

Data will be captured on specific patient types undergoing Blue Light Cystoscopy with Cysview for known or suspected non-muscle invasive bladder cancer. Specific clinical questions will be asked.

1. What is the incremental detection rate with Blue Light Cystoscopy with Cysview over conventional white light cystoscopy in each of the seven (7) patient populations? Does this translate into lower recurrence/progression rate?
2. How do the six (6) tumor variables used in the European Association of Urology (EAU) risk tables (primary/secondary, recurrence rate, size, multifocality, grade, and history of carcinoma in situ (CIS))6 affect this incremental rate?
3. How does an abnormal cytology or positive or negative fluorescent in situ hybridization (FISH) affect the likelihood that Blue Light Cystoscopy with Cysview will detect more cancers than white light?
4. What are the performance characteristics of Blue Light Cystoscopy with Cysview within eight (8) weeks of Bacillus Calmette-Guérin (BCG) with respect to improved tumor detection and false positive rate compared to conventional white light cystoscopy?
5. What is the incremental Blue Light Cystoscopy with Cysview detection rate over random bladder biopsies alone in patients being evaluated for routine three month restaging (group 4) or occult disease (group 5)?
6. What are the performance characteristics of Blue Light Cystoscopy with Cysview after repeated Blue Light Cystoscopy with Cysview evaluations with respect to improved tumor detection, false positive rate and safety compared to conventional white light?
7. Does an abnormal urinalysis help identify patients with inflammation more likely to have false positive Blue Light Cystoscopy with Cysview results?
8. What is the practical learning curve for becoming "proficient" with Blue Light Cystoscopy with Cysview?
9. What is the overall false positive rate with Blue Light Cystoscopy with Cysview?
10. Can Blue Light Cystoscopy with Cysview make the resection more complete? If yes, is this due to improved margins and/or additional tumors seen under blue light?

The Blue Light Cystoscopy with Cysview Registry is a web-based program supported by Global Vision Technologies. Data will be captured longitudinally over five (5) years on patients from each enrolled site. Each center will enter their respective site's patient data electronically.

Blue Light Cystoscopy With Cysview® Registry

Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone.

Rates of false-positive lesion biopsies based on pathological findings

Rate of additional margin detection with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone

Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview

Proportion of patients who have a cystectomy performed

Catalyst Pharmaceutical Research

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The enema will be administered to participant. Fluorescence sigmoidoscopy will be performed with white light then blue excitation light after retention of the enema for 60 minutes, followed by a rest time of up to 30 minutes before rectoscopy.

Post-operative surgical specimens will be collected for further fluorescence microscopy studies and pathological correlation of fluoresce with malignant pathology/histology as the gold standard.

250 mL enema containing 1.6 mmol of hexaminolevulinate

Cysview

This will be a pilot study involving 5 patients diagnosed with colorectal carcinoma and treated with pre-operative chemotherapy and external beam radiation therapy at the Jewish General Hospital, whom will very soon undergo surgery. Participants will be sensitized by the instillation of a 250 mL enema containing 1.6 mmol of HAL. The enema will be administered with a plastic tube with an inflatable blocking balloon to prevent leakage of the enema. Fluorescence sigmoidoscopy will be performed with white light then blue excitation light after retention of the enema for 60 minutes, followed by a rest time of up to 30 minutes before rectoscopy. Red fluorescence should be induced by illumination with blue light. Pictures with and without fluorescence will be taken. The patients will undergo a colectomy (partial or complete) within the next 2-3 days and the surgical specimens will be collected for further fluorescence microscopy studies and pathological correlation of fluoresce with malignant pathology/histology as the gold standard. The total concentration of porphyrins in the patients' urine and serum will be recorded before sensitization, immediately after sensitization (instillation of the enema), and approximately 24 hours after sensitization. The patients' pre-and-post operative liver function tests will be measured. Adverse events will be reported by direct questioning of all patients with regards to photosensitivity and gastrointestinal symptoms (nausea, vomiting), and by measuring blood pressure and heart rate. Our objectives and endpoints are: 1) to determine if fluorescence with photodynamic diagnostics is selective for colorectal cancer, 2) to determine if photodynamic diagnostics has the potential to improve the detection of malignant cell after neoadjuvant chemotherapy and radiation, and 3) to determine if photodynamic diagnostics can provide an accurate depiction of the extent of disease burden not visible with normal white light sigmoidoscopy to the naked human eye.

The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics

The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics (PDD): a Clinical Pilot Study

To observe red fluorescence wirh PDD when lesions are illuminate with blue fluorescence during fluorescence sigmoidoscopy.

Using the images of fluorescence sigmoidoscopy, detect malignant lesions after neoadjuvant chemotherapy and radiation.

Dr. Te Vuong

Director, Radiation Oncology Department

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting	NCT02560584	Bladder Cancer	Hexaminolevulin... KARL STORZ D-Li...	18 Years -	Photocure
Blue Light Cystoscopy With Cysview® Registry	NCT02660645	Bladder Cancer	Hexaminolevulin... Karl Storz D-Li...	18 Years -	Photocure
The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics	NCT03272659	Colorectal Canc... Photodynamic Di...	Cysview	-	Sir Mortimer B. Davis - Jewish General Hospital
The Correlation of Surgical Colorectal Cancer Specimen Pathology With the Fluorescence of Photodynamic Diagnostics	NCT03272659	Colorectal Canc... Photodynamic Di...	Cysview	-	Sir Mortimer B. Davis - Jewish General Hospital

Spots Global Cancer Trial Database for cysview

Every month we try and update this database with for cysview cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cysview

Every month we try and update this database with for cysview cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cysview cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.