Evaluation of hysteroscopic photo dynamic diagnosis for the diseases in the uterine cavity.

Not Applicable

• Conditions: diseases in the uterine cavity(ex: uterine myoma, endometrial polyp, uterine corpus cancer, endometr; diseases in the uterine cavity, uterine myoma, endometrial polyp, endometrial cancer, endometrial hyperplasia; D016889, D004714, D009214,

• Registration Number: JPRN-jRCTs031180123
• Lead Sponsor: Banno Kouji

Brief Summary

Hysteroscopic 5ALA-PDD has high diagnostic sensitivity (93.8%) for endometrial malignant disease. In addition, the diagnostic prediction formula from the image analysis could improve the diagnostic specificity. Also, oral 5ALA administration caused no severe adverse events. These our results suggest that 5ALA-PDD may be a feasible diagnostic approach for malignancies in the uterine cavity.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-14
• Study Completion: 2019-04-15
• Results First Posted: 2019-08-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

Patients who have diseases in uterine cavity.
Patients who plan to undergo hysteroscopic operation for those diseases at the department of obstetrics and gynecology of Keio university hospital.

Exclusion Criteria

1. under 20 years old
2. BMI>30
3. the medical history of endometrial entirely curettage in recent 14 day2.
4. the allergic history for the analog of the porphyrin.
5. 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 pregnant or blest feeding.
8. the diabetes mellitus and/or hyperlipidemia which is not controlled.
9. other endocrine diseases which are not controlled.
10. 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 for the malignant disease.

Secondary Outcome Measures

Name	Time	Method
relationship between pathological findings and strength of the fluorescence<br>adverse events (based on CTCAE v4.0-JCOG)