A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine

Transitional Cell Carcinoma of the Bladder Clinical Trial

— ALA  

Official title:

A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101931
• Other study ID #: E-13-1019
• Secondary ID: 14/4028/IRB
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2014
• Last updated: March 30, 2016
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2014
• Source: Princess Al-Johara Al-Ibrahim Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Research Problem:

Bladder cancer is one of the major health concerns of the world. The present methods of diagnosis are: Ultra sound, Cystoscopy, CT scan and urine cytology. All these are stressful to the patients, particularly Cystoscopy which is commonly employed for the follow up of Bladder cancer patients.

Research Significance:

The present study will employ a new photodynamic diagnostic procedure to quantify a certain cancer specific biomarker called Porphyrin, which selectively binds on to the bladder cancer tissues. In this context the present technique offer viable, very easy and reliable table top instrumentation for diagnosis and continual monitoring of disease regression through urine.

Research Objectives:

• To quantify bladder cancer specific biomarkers such as Porphyrin using photodynamic diagnostic procedure

• To find out whether this technique might be a new and easy tool for bladder cancer diagnosis only by urine.

Research Methodology:

The bladder cancer patients is required to swallow a chemical called ALA (5 Amino levulinic Acid hydrochloride), about 10mg/kg body weight which will play a role of biological indicator. ALA gets metabolized into certain types of porphyrins which selectively bind on to the tumor tissues (for a longer time than the normal tissues). 5ml of blood and one urine samples will be taken before using ALA. The patient must drink water then the urine will be collected after 4, 8 and 12 hours of taking ALA and the samples will be analyzed by photodynamic diagnostic procedure.

Description:

Bladder cancer is one of the most common urologic cancers in Saudi Arabia. its cases represent a significant and challenging part in the daily practice for the majority of urologists practicing. The present methods of diagnosis are: Ultra sound, Cystoscopy, CT-scan etc. All these are stressful to the patients, particularly Cystoscopy which is commonly employed for the follow up of Bladder cancer patients.

In recent years, fluorescence cystoscopy, in contrast to conventional white light cystoscopy, has been investigated as a tool to enhance detection of occult papillary lesions and carcinoma in situ. Recent fluorescence photo detection strategies have used 5-aminolevulinic acid (5-ALA); a precursor of heme biosynthesis.

5-Aminolevulinic acid-enhanced cystoscopy does appear to have improved sensitivities in detecting nonmuscle invasive bladder tumors such as carcinoma in situ . Aminolevulinic acid (ALA) may have a role in other applications in surgical oncology based on its ability to discriminate neoplastic tissue from adjacent normal tissue. Aminolevulinic acid is not a photosensitizer, but rather a metabolic precursor of porphyrin, which is a photosensitizer.

The present study will employ photodynamic diagnostic procedure to quantify only in urine a specific cancer biomarker Porphyrin which selectively binds on to the bladder cancer tissues for a longer time than the normal tissues. In this context, the present study will offer viable, very easy and reliable table top instrumentation for diagnosis and continual monitoring of disease regression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients: Urothelial (transitional cell) carcinoma. Early and advanced stages of with transitional cell carcinoma of the bladder before transurethral resection of bladder Tumor (TURBT) .

• Controls: Healthy volunteer's adults matched with age.

Exclusion Criteria:

• Urinary tract infection (UTI) patients

• Cardiac patients

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma of the Bladder
• Urinary Bladder Neoplasms

Intervention

Drug:
• Amino levulinic Acid
The bladder cancer patients is required to swallow a chemical called Amino levulinic Acid, about 10mg/kg body weight. 5ml of blood and one urine samples will be taken before using Amino levulinic Acid. The patient must drink water then the urine will be collected after 4, 8 and 12 hours of taking ALA and the samples will be analyzed by photodynamic diagnostic procedure. ALA gets metabolized into certain types of porphyrins which selectively bind on to the tumor tissues (for a longer time than the normal tissues).

Locations

Country	Name	City	State
Saudi Arabia	King Khalid University Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Princess Al-Johara Al-Ibrahim Cancer Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urine spectral profile after twelve hours	The bladder cancer patients is required to swallow a chemical called 5 Amino levulinic Acid hydrochloride (ALA), about 10mg/kg body weight. Urine will be collected after twelve hours of taking Amino levulinic Acid and the samples will be analyzed by photodynamic diagnostic procedure.	Twelve hours after taking Amino levulinic Acid	No
Primary	Urine spectral profile after four hours	The bladder cancer patients is required to swallow a chemical called 5 Amino levulinic Acid hydrochloride (ALA), about 10mg/kg body weight. Urine will be collected after four hours of taking Amino levulinic Acid and the samples will be analyzed by photodynamic diagnostic procedure.	Four hours after taking Amino levulinic Acid	No
Secondary	Urine spectral profile after eight hours	The bladder cancer patients is required to swallow a chemical called 5 Amino levulinic Acid hydrochloride (ALA), about 10mg/kg body weight. Urine will be collected after eight hours of taking Amino levulinic Acid and the samples will be analyzed by photodynamic diagnostic procedure.	Eight hours after taking Amino levulinic Acid	No