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

Primary Purpose

Transitional Cell Carcinoma of the Bladder

Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Amino levulinic Acid
Sponsored by
Princess Al-Johara Al-Ibrahim Cancer Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transitional Cell Carcinoma of the Bladder focused on measuring Bladder Cancer, Laser Diagnosis, Amino levulinic Acid, Photodynamic Detection, spectra of urine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • King Khalid University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Urine spectral analysis

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Urine spectral profile after eight 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 eight hours of taking Amino levulinic Acid and the samples will be analyzed by photodynamic diagnostic procedure.

Full Information

First Posted
March 26, 2014
Last Updated
March 30, 2016
Sponsor
Princess Al-Johara Al-Ibrahim Cancer Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02101931
Brief Title
A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine
Acronym
ALA
Official Title
A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Princess Al-Johara Al-Ibrahim Cancer Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transitional Cell Carcinoma of the Bladder
Keywords
Bladder Cancer, Laser Diagnosis, Amino levulinic Acid, Photodynamic Detection, spectra of urine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urine spectral analysis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Amino levulinic Acid
Other Intervention Name(s)
Gliolan, Levulan, Levulan Kerastick
Intervention Description
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).
Primary Outcome Measure Information:
Title
Urine spectral profile after four hours
Description
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.
Time Frame
Four hours after taking Amino levulinic Acid
Secondary Outcome Measure Information:
Title
Urine spectral profile after eight hours
Description
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.
Time Frame
Eight hours after taking Amino levulinic Acid
Other Pre-specified Outcome Measures:
Title
Urine spectral profile after twelve hours
Description
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.
Time Frame
Twelve hours after taking Amino levulinic Acid

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny M Rabah, Professor
Organizational Affiliation
College Of Medicine, King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Khalid University Hospital
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Results will be published in per-reviewed jounal

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

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