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

NCT02101931 | Completed Phase 3

• 2 other identifiers: E-13-101914/4028/IRB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Transitional Cell Carcinoma of the Bladder

Keywords

Bladder Cancer; Laser Diagnosis; Amino levulinic Acid; Photodynamic Detection; spectra of urine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Urine spectral profile after eight hours

  Eight hours after taking Amino levulinic Acid

Other Outcomes (1)

• Urine spectral profile after twelve hours

  Twelve hours after taking Amino levulinic Acid

Study Arms (1)

Urine spectral analysis

EXPERIMENTAL

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

Interventions

Amino levulinic Acid DRUG

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).

Also known as: Gliolan, Levulan, Levulan Kerastick

Urine spectral analysis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Urinary tract infection (UTI) patients
• Cardiac patients

Sponsors & Collaborators

• Princess Al-Johara Al-Ibrahim Cancer Research Center: lead

Study Sites (1)

King Khalid University Hospital

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Danny M Rabah, Professor

  College Of Medicine, King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 2, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2014-03

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)