Evaluation of the efficacy of hysteroscopic photodynamic diagnosis using 5-aminolevulinic acid for diseases in the uterine cavity.
- Conditions
- diseases in the uterine cavity (ex: uterine myoma, endometrial polyp, uterine corpus cancer, endometrial hyperplasia)
- Registration Number
- JPRN-UMIN000031637
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
The sensitivity and specificity of 5ALA-PDD for diagnosis of malignancy in the uterine cavity were 93.4% and 51.9%, respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 34
Not provided
1. under 20 years old 2. BMI>30 Patients who have 3. the medical history of full endometrial curettage in recent 14 days. 4. the allergic history for the analog of the porphyrin. 5. the history of porphyria 6. the medicine that is known for the cause of photosensitivity (ex. tetracycline antibacterial agent, medicine of sulfonamide, new quinolone antibacterial agent, hypericin and St.John's Wort. 7. the possibility of being pregnant or breast feeding 8. diabetes mellitus and/or hyperlipidemia which is not controlled. 9. other endocrine diseases which are not controlled. 10. Patients who are considered inadequate for this trial by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of the hysteroscopic photodynamic diagnosis using 5-ALA for malignant diseases.
- Secondary Outcome Measures
Name Time Method The relation of the histologic type and the strength of the fluorescence.