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The clinical trial on the safety and effectiveness of the photodynamic diagnosis of non-muscle-invasive bladder cancer using fluorescent light-guided cystoscopy after oral administration of 5-aminolevulinic acid (5-ALA).
- Source :
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Photodiagnosis and photodynamic therapy [Photodiagnosis Photodyn Ther] 2016 Mar; Vol. 13, pp. 91-96. Date of Electronic Publication: 2016 Jan 02. - Publication Year :
- 2016
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Abstract
- Objective: To examine the utility and safety of photodynamic diagnosis (PDD) after oral administration of 5-aminolevulinic acid (5-ALA) (ALA-PDD) of non-muscle-invasive bladder cancer (NMIBC) using fluorescent-light (FL)-cystoscopy.<br />Methods: The study was a single-arm, open-label, multi-center prospective study on ALA-PDD of NMIBC, with safety as the primary endpoint and efficacy as the secondary endpoint. Diagnostic potential was evaluated through comparisons with the conventional diagnostic method using a white-light (WL)-source. Clinically recommended doses were also examined. Oral administration of 5-ALA (1.0g/50mL) was performed 180-240min before FL-cystoscopy, and positive or negative results were judged using a WL-source and based on presence or absence of red fluorescence on exposure to a blue FL-source.<br />Results: Regarding safety, the adverse drug reactions were observed as grade 1 pruritus in 1 patient (0.6%). As for efficacy, specificity and positive predictability were lower than those of a WL-source, but sensitivity was higher with a FL-source than with a WL-source. The proportion of patients with tumors detected only by FL-cystoscopy was greater than the proportion of patients with tumors detected only by conventional WL-cystoscopy. Moreover, not only sensitivity, but also the proportion of patients with tumors detected only by FL-cystoscopy, was highest among patients who received 5-ALA at ≧20mg/kg/body.<br />Conclusions: ALA-PDD was shown to be safe and effective. Furthermore, diagnostic accuracy of PDD increased with increased dose of 5-ALA, and the recommended dose was determined as ≧20mg/kg/body in the present study.<br /> (Copyright © 2016 Elsevier B.V. All rights reserved.)
- Subjects :
- Administration, Oral
Adult
Aged
Aged, 80 and over
Aminolevulinic Acid adverse effects
Contrast Media administration & dosage
Cystoscopy adverse effects
Dose-Response Relationship, Drug
Female
Humans
Japan
Male
Middle Aged
Muscle, Smooth pathology
Neoplasm Invasiveness
Photosensitizing Agents administration & dosage
Photosensitizing Agents adverse effects
Surgery, Computer-Assisted adverse effects
Treatment Outcome
Urinary Bladder Neoplasms pathology
Aminolevulinic Acid administration & dosage
Cystoscopy methods
Microscopy, Fluorescence methods
Surgery, Computer-Assisted methods
Urinary Bladder Neoplasms diagnostic imaging
Urinary Bladder Neoplasms surgery
Subjects
Details
- Language :
- English
- ISSN :
- 1873-1597
- Volume :
- 13
- Database :
- MEDLINE
- Journal :
- Photodiagnosis and photodynamic therapy
- Publication Type :
- Academic Journal
- Accession number :
- 26751700
- Full Text :
- https://doi.org/10.1016/j.pdpdt.2015.12.011