ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 2463 for:    ALA

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02101931
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Princess Al-Johara Al-Ibrahim Cancer Research Center

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.


Condition or disease Intervention/treatment Phase
Transitional Cell Carcinoma of the Bladder Drug: Amino levulinic Acid Phase 3

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  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine
Study Start Date : March 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


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:
  • Gliolan
  • Levulan
  • Levulan Kerastick




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101931


Locations
Saudi Arabia
King Khalid University Hospital
Riyadh, Saudi Arabia
Sponsors and Collaborators
Princess Al-Johara Al-Ibrahim Cancer Research Center
Investigators
Principal Investigator: Danny M Rabah, Professor College Of Medicine, King Saud University

Responsible Party: Princess Al-Johara Al-Ibrahim Cancer Research Center
ClinicalTrials.gov Identifier: NCT02101931     History of Changes
Other Study ID Numbers: E-13-1019
14/4028/IRB ( Registry Identifier: Institutional Review Board )
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be published in per-reviewed jounal

Keywords provided by Princess Al-Johara Al-Ibrahim Cancer Research Center:
Bladder Cancer
Laser Diagnosis
Amino levulinic Acid
Photodynamic Detection
spectra of urine

Additional relevant MeSH terms:
Aminolevulinic Acid
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Levulinic acid
Photosensitizing Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action