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Evaluation of the efficacy of hysteroscopic photodynamic diagnosis using 5-aminolevulinic acid for diseases in the uterine cavity.

Evaluation of the efficacy of hysteroscopic photodynamic diagnosis using 5-aminolevulinic acid for diseases in the uterine cavity. - Evaluation of hysteroscopic photo dynamic diagnosis for the diseases in the uterine cavity.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031637
Enrollment
30
Registered
2018-03-08
Start date
2018-03-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diseases in the uterine cavity (ex: uterine myoma, endometrial polyp, uterine corpus cancer, endometrial hyperplasia)

Interventions

3 hours before operation, patients will take the 5-aminolevulinic acid(20 mg/kg) once. 3 hours later, they will be performed photodynamic diagnosis under the hysteroscopy. During the operation, they
ll resect other lesions under the white light if we can find any in addition. When the resection is finished, we will do curettage if we need. We will investigate all samples histopathologically.

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients who have diseases in the uterine cavity (including both of benign and malignant). Patients who plan to undergo hysteroscopic operation for those diseases at the Department of Obstetrics and Gynecology of Keio University Hospital

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of the hysteroscopic photodynamic diagnosis using 5-ALA for malignant diseases.

Secondary

MeasureTime frame
The relation of the histologic type and the strength of the fluorescence.

Countries

Japan

Contacts

Public ContactYusuke Matoba

Keio University School of Medicine Department of Obstetrics and Gynecology

y.matoba0212@gmail.com03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026