Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Carcinoma

Carcinoma in Situ

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

hexaminolevulinate

biopsy

cystoscopy

Peter Schulam, MD

RATIONALE: Diagnostic procedures such as cystoscopy may improve the ability to detect cancer and to determine the extent of disease.

PURPOSE: Diagnostic trial to compare the effectiveness of cystoscopy using hexyl 5-aminolevulinate and two light sources in detecting carcinoma in situ in patients who have bladder cancer.

OBJECTIVES:

* Compare blue light fluorescent cystoscopy with reconstituted hexyl 5-aminolevulinate (Hexvix®) vs white light cystoscopy for the detection of carcinoma in situ (CIS) in patients with bladder cancer.
* Compare the positive and false detection rates of histologically confirmed non-CIS lesions and dysplasia by these modalities in these patients.
* Compare the false detection rate of histologically confirmed CIS lesions by these modalities in these patients.
* Compare the number of tumor lesions and dysplasia detected by these modalities in these patients.
* Compare management of patients after evaluation with these modalities.
* Determine the safety of reconstituted hexyl 5-aminolevulinate (Hexvix®) in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients undergo bladder catheterization and instillation of reconstituted hexyl 5-aminolevulinate (Hexvix®). After 60 minutes the bladder is evacuated, and the patient undergoes cystoscopic examination of the bladder by white light and then blue light fluorescence. Biopsies are taken of all suspicious areas seen under white and/or blue light modalities, and one normal-appearing area seen under both light modalities, and papillary lesions are resected.

Patients are followed at 7 days after procedure.

PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study within 1 year.

Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer

An Open, Comparative, Within Patient, Controlled Phase III, Multicenter Study Of HEXVIX Fluorescence Cystoscopy And White Light Cystoscopy In the Detection Of Carcinoma In Situ In Patients With Bladder Cancer

National Cancer Institute (NCI)

Photocure

Digestive System Diseases

Polyps

Precancerous Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Fluoxymesterone

Cola

Brigitte Mayinger, MD, PhD

Patients referred for colon inspection (colonoscopy) due to suspicion of colon polyps/cancer will receive local administration of hexaminolevulinate (HAL) prior to colon inspection. Blue light illumination will induce red fluorescence of polyps and tumours, improving detection of the polyps and tumors. Different HAL doses will be tested to find the optimal image conditions. Tolerability measurements will be performed to ensure patient safety.

Colonoscopy is regarded as the "gold standard" for diagnosis of colorectal cancer. The sensitivity is uncertain but proposed to be (75-95%), however flat adenomas which are easily missed, are often not recognised. Fluorescence imaging may increase the sensitivity of standard white light colonoscopy by identifying more polyps and flat adenomas which will make the resection of adenomas more complete.

In this study hexaminolevulinate (HAL) will be administered locally as a photosensitiser, using different doses to find the optimal imaging conditions as well as making patient safety assessments.

Both standard white light and blue light (fluorescence) inspection will be performed.

Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study

Early Detection of Pre-malignant and Malignant Conditions in the Colon by Means of Fluorescence Endoscopy Using Local and Oral Sensitisation With Hexaminolevulinate (HAL) - a Dose Finding Study

KARL STORZ Endoscopy-America, Inc.

Rare Diseases

Uterine Cervical Dysplasia

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Cervical Intraepithelial Neoplasia

Pharmaceutical Solutions

Methyl 5-aminolevulinate

Photosensitizing Agents

MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application

methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

Peter Hillemanns, Md PhD

The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).

Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients.

This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.

A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding 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

Disease Attributes

Antineoplastic Agents

Mitomycins

Mitomycin

One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.

Multiple instillations of mitomycin C after transurethral resection in white light alone.

Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.

Jean-Paul Antonini

This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).

Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

GE Healthcare

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.

Hexvix

Age, Categorical

Age, Continuous

Sex: Female, Male

Spain

Region of Enrollment

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

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cystoscopy and Hexyl 5-Aminolevulinate in Detecting Carcinoma In Situ in Patients With Bladder Cancer	NCT00052637	Bladder Cancer	hexaminolevulin... biopsy cystoscopy	18 Years -	Photocure
Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study	NCT00285701	Colorectal Canc...	hexaminolevulin...	18 Years - 85 Years	Photocure
A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.	NCT00369018	Cervical Dyspla...	methyl aminolev...	18 Years -	Photocure
Blue Light Cystoscopy With Cysview® Registry	NCT02660645	Bladder Cancer	Hexaminolevulin... Karl Storz D-Li...	18 Years -	Photocure
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix	NCT00785694	Bladder Cancer	hexaminolevulin...	18 Years -	GE Healthcare
Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer	NCT00634621	Bladder Cancer	Hexaminolevulin...	18 Years -	GE Healthcare
Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study	NCT00285701	Colorectal Canc...	hexaminolevulin...	18 Years - 85 Years	Photocure
Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study	NCT00285701	Colorectal Canc...	hexaminolevulin...	18 Years - 85 Years	Photocure

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