A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine
Conditions
Transitional Cell Carcinoma of the Bladder
Conditions: official terms
Carcinoma, Transitional Cell - Urinary Bladder Neoplasms
Conditions: Keywords
Bladder Cancer, Laser Diagnosis, Amino levulinic Acid, Photodynamic Detection, spectra of urine
Study Type
Interventional
Study Phase
Phase 3
Study Design
Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Intervention
Name: Amino levulinic Acid
Type: Drug
Overall Status
Recruiting
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: 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
Location
King Khalid University Hospital
Riyadh, Saudi Arabia
Status: Recruiting
Contact: karim H Farhat, PhD - 14679748 - farhatscience@yahoo.fr
Start Date
March 2014
Completion Date
April 2016
Sponsors
Princess Al-Johara Al-Ibrahim Cancer Research Center
Source
Princess Al-Johara Al-Ibrahim Cancer Research Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page