Clinical trial NCT02101931: A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine
Official title: A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transitional Cell Carcinoma of the Bladder
Keywords: Bladder Cancer
Laser Diagnosis
Amino levulinic Acid
Photodynamic Detection
spectra of urine
Lead sponsor: Princess Al-Johara Al-Ibrahim Cancer Research Center
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility 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

Primary outcomes:
measure: Urine spectral profile after four hours
timeFrame: Four hours after taking Amino levulinic Acid
Secondary outcomes:
measure: Urine spectral profile after eight hours
timeFrame: Eight hours after taking Amino levulinic Acid
Other outcomes:
measure: Urine spectral profile after twelve hours
timeFrame: Twelve hours after taking Amino levulinic Acid
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospital
Study officials:
affiliation: College Of Medicine, King Saud University
name: Danny M Rabah, Professor
role: PRINCIPAL_INVESTIGATOR
References: