Hexaminolevulinate

Generic Name: Hexaminolevulinate

Brand Names: Cysview

Drug Type: Small Molecule

Chemical Formula: C_₁₁H_₂₁NO_₃

CAS Number: 140898-97-1

Unique Ingredient Identifier: G7H20TKI67

Background: Hexaminolevulinate is an optical imaging drug. In solution form it is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. On May 28, 2010, the U.S. Food and Drug Administration (FDA) granted approval for hexaminolevulinate hydrochloride (Cysview for Intravesical Solution, Photocure ASA), as an optical imaging agent for use in combination with the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Hexaminolevulinate is manufactured under the brand Cysview® by Photocure ASA. In Europe, Hexaminolevulinate is marketed under the brand Hexvix®.

Indication: Hexaminolevulinate is indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.

Associated Conditions: Bladder Carcinoma, Carcinoma in situ of urinary bladder

Clinical Trials

Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection

Phase 3

Recruiting

Conditions: Bladder Cancer

Interventions: Drug: Cysview
Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

First Posted Date: 2024-07-29

Last Posted Date: 2025-01-10

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 200

Registration Number: NCT06525571

Locations: 🇺🇸
Sibley Memorial Hospital, Washington, District of Columbia, United States
🇺🇸
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)

Phase 4

Not yet recruiting

Conditions: Non-muscle-invasive Bladder Cancer
Non-Muscle Invasive Bladder Urothelial Carcinoma
High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma

Interventions: Drug: PDD-TURBT with hexaminolevulinate (Hexvix®)
Device: Power Led Saphira (TM)

First Posted Date: 2023-07-27

Last Posted Date: 2025-03-25

Lead Sponsor: University of Roma La Sapienza

Target Recruit Count: 258

Registration Number: NCT05962541

Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer

Phase 3

Completed

Conditions: Bladder Cancer

Interventions: Drug: Hexaminolevulinate Hydrochloride
Device: Richard Wolf Photodynamic Diagnostic Equipment (PDD) system

First Posted Date: 2022-10-31

Last Posted Date: 2024-10-03

Lead Sponsor: Photocure

Target Recruit Count: 158

Registration Number: NCT05600322

Locations: 🇨🇳
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
🇨🇳
Peking University Third Hospital, Beijing, Beijing, China
🇨🇳
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangzhou Province, China

and more 4 locations

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

Phase 2

Withdrawn

Conditions: Colorectal Cancer
Photodynamic Diagnosis

Interventions: Drug: Cysview

First Posted Date: 2017-09-05

Last Posted Date: 2019-09-18

Lead Sponsor: Dr. Te Vuong

Registration Number: NCT03272659

Near Infrared Fluorescence Imaging for Bladder Cancer Detection

Not Applicable

Completed

Conditions: Bladder Cancer

Interventions: Drug: Hexaminolevulinate HCL
Device: Near Infrared Fluorescence (NIRF)

First Posted Date: 2017-02-23

Last Posted Date: 2019-08-19

Lead Sponsor: Edward Messing

Target Recruit Count: 10

Registration Number: NCT03058705

Locations: 🇺🇸
University of Rochester Medical Center, Rochester, New York, United States

Blue Light Cystoscopy With Cysview® Registry

Recruiting

Conditions: Bladder Cancer

Interventions: Drug: Hexaminolevulinate hydrochloride (HCL)
Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

First Posted Date: 2016-01-21

Last Posted Date: 2024-08-15

Lead Sponsor: Photocure

Target Recruit Count: 4400

Registration Number: NCT02660645

Locations: 🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Northshore University Health System, Evanston, Illinois, United States
🇺🇸
University of California Los Angeles, Los Angeles, California, United States

and more 20 locations

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

Phase 3

Completed

Conditions: Bladder Cancer

Interventions: Drug: Hexaminolevulinate hydrochloride
Device: KARL STORZ D-Light C PDD Flexible Videoscope System

First Posted Date: 2015-09-25

Last Posted Date: 2018-07-02

Lead Sponsor: Photocure

Target Recruit Count: 304

Registration Number: NCT02560584

Locations: 🇺🇸
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
University of North Carolina, Department of Urology, Chapel Hill, North Carolina, United States

and more 14 locations