Detection of Bladder Tumors After 30 Min Instillation of Hexvix

NCT01551407 | Terminated Phase 2

• 1 other identifier: PC B202/11
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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®.

Conditions

Bladder Cancer

Keywords

Hexvix; bladder cancer; cystoscopy; Patients with known or suspicion of bladder cancer

Outcome Measures

Primary Outcomes (1)

• Number of lesions

  An average of 15 min (during cystoscopy)

Secondary Outcomes (1)

• Drug related adverse events

  From time of drug instillation until 24 hours after cystoscopy

Interventions

Hexvix DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with multiple bladder tumors, defined as ≥2 lesions, based on an outpatient cystoscopy.
• Patients with known urinary urge symptoms or patients who have problems or pain holding back the urine for a time longer than 30 minutes.
• Age 18 years or above

You may not qualify if:

• Patients with known tumors in the prostatic urethra or distal urethra
• Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
• Patient with porphyria.
• Hypersensitivity to the active substance or to any of the excipients of the solvent
• Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
• Women of child-bearing potential meaning that only post-menopausal women, women who had their ovaries removed, and women who are otherwise physically unable to bear children can be included.
• Conditions associated with a risk of poor protocol compliance.
• Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the clinical study.
• Patients unlikely to comply with protocol

Sponsors & Collaborators

• Photocure: lead

Study Sites (1)

LMU Munich

Munich, Munich, D-81377, Germany

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Alexander Karl, MD

  Department of Urology, LMU Munich, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 12, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

DE (1)