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Hexvix

Standard white light cystoscopy

Gregers G Hermann, MD, DM Sci

The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.

The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.

The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.

Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen is according to standard clinical practice in Denmark.

Recurrence of non-invasive bladder cancer is frequent, and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB

A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer

A Randomized, Comparative Phase III, 2-center Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer

To compare tumour recurrence rates after standard (white light) and fluorescence guided transurethral resection of the bladder (TURB) in patients with macroscopic non-muscle invasive bladder tumour.

Photocure

Hexvix Cystoscopy Group

White Light

Total

Age Continuous

Female

Male

Gender

Denmark

Region of Enrollment

Gregers G. Hermann

PP. 145 patients were eligible for tumor recurrence. 12 patients has their last follow up after 12 months. Recurrence after 12 months is based on a total of 133 patients.

Proportion of Patients With Histologically Confirmed Recurrence Within One 1 Year.

Proportion of Patients in the Hexvix Cystoscopy Group Who Had at Least One Additional Lesion Found by Hexvix Cystoscopy That Was Not Found by White Light Cystoscopy.

False Positive Detection Rate Patient Level

Overall Study

Pharmaceutical Solutions

All Drugs and Chemicals

Dermatologic Agents

Aminolevulinic Acid

Photosensitizing Agents

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

Each patient enrolled into the study will be infused with 50 mL of a 2 mg/mL Hexvix solution in the bladder using a catheter. Subsequently, after fluid retention by the patient in the bladder for one hour, the bladder will be emptied.

Hexaminolevulinate (Hexvix)

Dr. Carlos Hernández

Dr. Eduardo Solsona

Dr. Joan Palou

The purpose of this study is to determine the effectiveness of hexaminolevulinate (Hexvix) in the diagnosis and treatment of patients with non-invasive bladder cancer and if it results in a change in patient management.

Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer

A Post-authorization, Observational Study to Assess the Impact of Blue Light Cystoscopy After Administration of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer.

Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.

The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy.

GE Healthcare

Age, Categorical

Age, Continuous

Sex: Female, Male

Spain

Emilio Moreno Carretero, M.D.

Tumor Stage-Carcinoma in situ

Tumor Stage-Ta

Tumor Stage- T1

Tumor Stage- T2-T4

Tumor could not be stage-Tx

TOTAL

Hexvix administered using both White-light and Blue-Light Cystoscopy.

White-light and Blue-Light Cystoscopy Simultaneously

Hexvix administered using only White-light Cystoscopy.

White-light Cystoscopy Only

Hexvix administered using only Blue-light Cystoscopy.

Blue-light Cystoscopy Only

Multiple Normalized Biopsy

Number of True-positive lesions according to histology was 621 and broken out into various tumor stages. The Tumor stage distribution of true-positive bladder tumor lesions and their detection by White-light Cystoscopy (WLC) and/or Blue-light Cystoscopy (BLC).

Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy.

White-Light Cystoscopy-Sensitivity

Blue-Light Cystoscopy-Sensitivity

Using the Hexvix drug with a cystoscopy technique of White-light cystoscopy and Blue-light cystoscopy.

Confirmed Bladder Cancer by Standard of Truth

The number of confirmed bladder cancer was 219 identified by the standard of truth methods using the White-light cystoscopy and blue-light cystoscopy technique.

Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level.

Hexvix 2 mg/mL Infusion

Disease Attributes

Single Instillation, Transurethral Resection of the Bladder

H Barton Grossman

The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer.

In superficial bladder cancer macroscopic tumors including non-invasive papillary tumors (Ta) in the bladder are relatively easy to visualize by cystoscopic examination under white light. However, dysplasia, carcinoma in situ (CIS) or small exophytic tumors are easily overlooked. These lesions are predictive of recurrence and progression of disease, and the identification of these lesions is a crucial factor for the prognosis of the patient. The present situation with 50-75% recurrence rate show the inadequacy of white light cystoscopy for detection and resection of the lesions.

A better detection of papillary bladder cancer and early detection of CIS lesions will provide the patient with a more complete TURB, a more optimal pharmacological treatment when needed, may reduce the need for follow up cystoscopies and hopefully result in a better prognosis for the patient.

The aim of the present study is to compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer and to compare early recurrence rate after Hexvix and white light transurethral resection (TURB) with white light TURB in patients with superficial bladder cancer.

Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy

A Randomized, Comparative, Controlled Phase III, Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection Of Papillary Bladder Cancer and the Early Recurrence Rate in Patients With Bladder Cancer

The false detection rate for Hexvix cystoscopy was calculated as the total number of false positive lesions (i.e. lesions that were suspected with blue light but had negative histology according to the Standard of Truth central panel read) divided by the total number of lesions that were suspected with blue light (i.e., false positive divided by false positive plus true positive).

The corresponding false detection rates were also calculated for white light cystoscopy for the two groups separately.

Comparator

Standard White Light and Hexvix Fluorescence Cystoscopy

Hexvix Fluorescence Cystoscopy

Yngvil Kloster Thomas

The primary endpoint was assessed from patients randomized to the Hexvix group only

Hexvix Group

White Light Group

Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light

Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months.

Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.

Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.

50 ml Hexvix liquid instilled once into the bladder for 30 minutes prior to cystoscopy

Alexander Karl, MD

The objective of the study is to compare Hexvix® flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.

This study is an open, prospective, within patient, controlled, multi-center, Phase IIa study in patients with bladder cancer.

The bladder of all patients will be instilled with 50 mL Hexvix® 8 mM solution and evacuated after 30 minutes. After bladder evacuation, the bladder will be examined under white light cystoscopy using the Karl Storz flexible videocystoscope. Tumors visible under white light will be mapped. Then the bladder is evaluated with blue light and lesions seen by blue light will be mapped. Biopsies of all visible tumors will be taken using both white and blue light prior to resection of all lesions.

Detection of Bladder Tumors After 30 Min Instillation of Hexvix

Open Prospective Within Patient, Phase IIa Study of Hexvix Flexible Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer After 30 Minutes Instillation of Hexvix in Patients With Known or Suspicion of Bladder Cancer

Patients with a suspicion of a bladder cancer or suspected recurrence of bladder cancer will have a cystoscopy under their care.

Patients will be randomized to know the order of carrying out cystoscopy with one or the other medical devices.

24 hours and 48 hours after the exam, a nurse will contact the patient to detect potential adverse effects

Strorz (commercial)

CyPaM2 (experimental)

ESCHWEGE PASCAL, Pr

This study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of the inner bladder using white light and blue light excitations and (ii) high resolution panoramic images of the bladder inner wall.

All participants will undergo fluorescence cystoscopy: the first half using first a reference medical device for fluorescence cystoscopy already on the market then using the innovative device specifically developped for the CyPaM2 project.

The other half will undergo fluorescence cystoscopy using first the innovative then the reference medical device.

An innovative medical device was developped by the CyPaM2 project's partners.This device is made of a hardware and of a software part: (i) an imager (light source and sensors) for simultaneous and colocalized visualisation of the bladder using white light and blue light for fluorescence excitation and (ii) a mosaicing software for automatic building of high-resolution panoramic images of the bladder inner wall. The medical device's qualitative (human engineering, images qualitty) and quantitative (medical examination and panoramic images building durations) specifications will be evaluated during the clinical trial in comparison with a reference medical device already on the market. The main goals are to achieve (i) better sensitivity of bladder cancers' cystocopic diagnosis and shorter medical examination durations thanks to the simultaneous visualization of the bladder inner wall with white and blue lights and (ii) better patients' follow up thanks to the high resolved panoramic images.

Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection

Evaluation of an Innovative Medical Device Made of a Bimodal Endoscopic Imager and of a Software for Panoramic Images Building of the Bladder Inner Wall (French National Research Agency, CyPaM2 Project, ANR-11-TECS-001) (CyPaM2)

Ergonomic of the two devices will be evaluated and compared by using the scale NASA TLX (Hart SG, et al., 1998).

Performing time of medical examination with both devices will be evaluated and compared

Image quality : sharpness and colorimetry will be assessed by the physician using a self-questionnaire.

Device quality : sensitivity and accuracy will be assessed by the urologist using a self-questionnaire

Recording capacity of the video sequences to perform real-time image mosaics will be assessed by the physician using a self-questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer	NCT00412971	Bladder Cancer	Hexvix Standard white ...	18 Years -	Photocure
Blue Light Cystoscopy With Cysview® Registry	NCT02660645	Bladder Cancer	Hexaminolevulin... Karl Storz D-Li...	18 Years -	Photocure
Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer	NCT00634621	Bladder Cancer	Hexaminolevulin...	18 Years -	GE Healthcare
Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy	NCT00233402	Bladder Cancer	Hexvix Standard white ...	18 Years -	Photocure
Detection of Bladder Tumors After 30 Min Instillation of Hexvix	NCT01551407	Bladder Cancer	Hexvix	18 Years -	Photocure
Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection	NCT02800473	Bladder Cancer	Strorz (commerc... CyPaM2 (experim...	18 Years -	Institut de Cancérologie de Lorraine

Spots Global Cancer Trial Database for hexvix

Every month we try and update this database with for hexvix 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 hexvix

Every month we try and update this database with for hexvix 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 hexvix 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.