Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer
This study has been completed.
Information provided by (Responsible Party):
First received: February 26, 2008
Last updated: December 5, 2013
Last verified: December 2013
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.
Drug: Hexaminolevulinate (Hexvix)
||Observational Model: Case-Only
Time Perspective: Prospective
||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.
Primary Outcome Measures:
- The primary objective of this study is to quantify the increase in sensitivity for detection of non-invasive bladder cancer with blue light fluorescence cystoscopy using hexaminolevulinate (Hexvix) as compared to standard white light cystoscopy. [ Time Frame: Since cystoscopy until pathology results are available. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To ascertain whether use of hexaminolevulinate (Hexvix) for diagnosis of non-invasive bladder cancer results in a change in patient management. [ Time Frame: At the end of study. ] [ Designated as safety issue: No ]
- To assess the safety profile of Hexvix in daily clinical practice. [ Time Frame: Between the administration of Hexvix and 72 hours following this administration. ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2010 (Final data collection date for primary outcome measure)
Drug: Hexaminolevulinate (Hexvix)
Each patient enrolled into the study will be instilled 50 mL of a 8 mmol/L 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with documented or suspected bladder cancer.
- Patients over 18 years of age.
- Patients of either sex.
- Patients with documented or highly suspected non-invasive bladder cancer.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634621
|Madrid, Spain, 28108 |
||Dr. Carlos Hernández
||Gregorio Marañón Hospital, Madrid
||Dr. Eduardo Solsona
||Valencian Institute of Oncology, Valencia
||Dr. Joan Palou
||Fundación Puigvert, Barcelona
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 26, 2008
||December 5, 2013
||Spain: Spanish Agency of Medicines
Keywords provided by GE Healthcare:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 20, 2014
Urinary Bladder Neoplasms
Neoplasms by Site
Urinary Bladder Diseases