NCT02101931: ALA

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

Completed Phase 3 Last updated 30 March 2016

What this trial tests

Phase 3 trial testing Amino levulinic Acid in Transitional Cell Carcinoma of the Bladder in 100 participants. Completed in 1 March 2016.

Timeline

1 March 2014

Primary endpoint
1 March 2016

1 March 2016

Quick facts

Lead sponsor	Princess Al-Johara Al-Ibrahim Cancer Research Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	single
Primary purpose	diagnostic
Enrollment	100
Start date	1 March 2014
Primary completion	1 March 2016
Estimated completion	1 March 2016
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Amino levulinic Acid — full drug profile →

Conditions studied

• Transitional Cell Carcinoma of the Bladder — all drugs for Transitional Cell Carcinoma of the Bladder →

Sponsor

Princess Al-Johara Al-Ibrahim Cancer Research Center — full company profile →

Who can join

Eligibility, any sex, with Transitional Cell Carcinoma of the Bladder. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Urine spectral profile after four hours
  Time frame: Four hours after taking Amino levulinic Acid
  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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.