Symptoms and General Pathology

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Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Urinary Bladder Neoplasms

Urologic Neoplasms

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Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

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

Spots Global Cancer Trial Database for recurrence of bladder cancer