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

March 30, 2016 updated by: Princess Al-Johara Al-Ibrahim Cancer Research Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Khalid University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Urine spectral analysis
The patient must drink water then the urine will be collected after 4, 8 and 12 hours of taking Amino levulinic Acid and the samples will be analyzed by photodynamic diagnostic procedure. Amino levulinic Acid gets metabolized into certain types of porphyrins which selectively bind on to the tumor tissues (for a longer time than the normal tissues).The above samples is taken in a four side polished quartz cuvette of 1cmx1cmx4cm and put into the table top spectral scan. This consists of a 5 mw, blue diode laser, of 405nm wavelength. The collimated laser beam falls on the urine sample and excites fluorescence and Raman signals from the porphyrin molecules which have been metabolized from the oral administration of Amino levulinic Acid.
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).
Other Names:
  • Levulan Kerastick
  • Gliolan
  • Levulan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four hours after taking Amino levulinic Acid

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine spectral profile after eight hours
Time Frame: Eight 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 eight hours of taking Amino levulinic Acid and the samples will be analyzed by photodynamic diagnostic procedure.
Eight hours after taking Amino levulinic Acid

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine spectral profile after twelve hours
Time Frame: Twelve 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 twelve hours of taking Amino levulinic Acid and the samples will be analyzed by photodynamic diagnostic procedure.
Twelve hours after taking Amino levulinic Acid

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Al-Johara Al-Ibrahim Cancer Research Center

Investigators

  • Principal Investigator: Danny M Rabah, Professor, College Of Medicine, King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

March 30, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-13-1019
  • 14/4028/IRB (Registry Identifier: Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results will be published in per-reviewed jounal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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