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

NCT00634621 | Completed Results

• 1 other identifier: GEH-HEX-2007-01
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

Bladder; Cancer; Cystoscopy; Hexaminolevulinate; Hexvix

Outcome Measures

Primary Outcomes (1)

• 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.

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

  Day 0 (Post contrast administration)

Secondary Outcomes (1)

• 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.

  Day 0 (Post contrast administration)

Interventions

Hexaminolevulinate (Hexvix) DRUG

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.

Eligibility Criteria

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

Study Population

Patients with documented or suspected bladder cancer.

You may qualify if:

• Patients over 18 years of age.
• Patients of either sex.
• Patients with documented or highly suspected non-invasive bladder cancer.

You may not qualify if:

• Patients with hypersensitivity to the drug substance or any excipient of Hexvix.
• Patients with porphyry.
• Women of childbearing age.
• Patients at a high risk of suffering extensive bladder inflammation e.g. patients after intravesical BCG treatment, patients with moderate or severe leukocyturia or patients undergoing recent bladder surgery.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

GE Healthcare

Madrid, 28108, Spain

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Emilio Moreno Carretero, M.D.
• Organization: GE Healthcare

Emilio.Morenocarretero@ge.com

011-34-9166-30970

Study Officials

• Dr. Carlos Hernández

  Gregorio Marañón Hospital, Madrid

  PRINCIPAL INVESTIGATOR

• Dr. Eduardo Solsona

  Valencian Institute of Oncology, Valencia

  PRINCIPAL INVESTIGATOR

• Dr. Joan Palou

  Fundación Puigvert, Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2008
• First Posted: March 13, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 25, 2014
• Results First Posted: August 25, 2014

Record last verified: 2014-08

Locations

ES (1)