Study of the effects of photodynamic therapy for patients with cervical intraepithlial neoplasia on vaginal bacteria

JRCT ID: jRCTs041230002

Registered date:05/04/2023

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Cervical intraepithelial neoplasia
• Date of first enrollment: 05/04/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

1.Investigational agent administration
One hundred milligrams of talaporfin sodium are dissolved in 4 mL of saline, and a 40 mg/m2 dose is slowly injected intravenously.
2. Investigational equipment and laser irradiation method
Four to 6 hours after administration of talaporfin sodium, the cervical and endocervical lesions are irradiated with diode laser at a 664 nm wave- length.
The fluence is set at 100 J/cm2 with a fixed fluence rate of 150 mW/cm2.
The operator uses a direct shot probe to irradiate cervical lesion and a side shot probe to irradiate endocervical lesion.

Outcome(s)

• Primary Outcome: Changes in vaginal bacterial cultures before and after photodynamic therapy (PDT) with ME2906 and PNL6405CIN in patients with cervical intraepithelial tumors

Secondary Outcome

Final judgment of treatment response: CR (complete response) rate (complete response rate)
HR HPV (High risk human papillomavirus) negative result rate
Evaluation of treatment response by conical resection after CR (only for patients who have given consent)
Incidence of adverse events and diseases
Incidence of adverse events, diseases, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1.Female patients who are at least 18 years of age at the time consent is obtained
2. Patients diagnosed with CIN2 or CIN3 as a result of sub-colposcopic targeted histology (sub-colposcopic targeted histology) (specimen from the performing facility or specimen from a facility prior to referral that confirmed the lesion)
3.Patients with a PS (Performance status) [ECOG (Eastern cooperation oncology group)] of 0 or 1
4. Patients whose screening test results meet all of the following criteria and whose major organs are sufficiently functional
1) White blood cell count: >3,000/mm3
2) Platelet count: >-100,000/mm3
3) AST, ALT: less than twice the upper limit of the facility standard value
4)Total bilirubin: 2.0 mg/dL or less
5) BUN, serum creatinine: 1.5 times or less than the upper limit of the institutional reference value
5. Patients who have given written consent to participate in the study

Exclude criteria

1) Patients with adenodysplasia, intraepithelial adenocarcinoma, squamous cell carcinoma or other cervical malignancy.
2) Patients with UCF (Unsatisfactory colposcopic findings) or TZ type 3 with deep cervical lesions by colposcopy
3) Patients with multiple cancers
4) Patients with poorly controlled cardiac, respiratory, hepatic, renal, gastrointestinal, hematologic, endocrine, neurological or psychiatric diseases
5) Patients with pre-existing or concomitant photosensitivity
6) Patients with porphyria
7) Patients who have undergone PDT using talaporphine sodium or porphymer sodium in the past
8) Pregnant or possibly pregnant women, lactating women, and female patients who wish to become pregnant by the end of the observation period of this study (maximum 24 weeks after PDT)
9) Patients who are unable to use an appropriate contraceptive method (condom, pessary, etc.) or who cannot obtain consent for appropriate contraception from the time consent is obtained until the completion of the observation period of this study (24 weeks after the maximum PDT)
10) Patients who are currently participating in another clinical trial or who have not completed at least 3 months of participation
11) Other patients who are judged by the principal investigator or subinvestigator to be inappropriate as subjects for this study.

Related Information

• Primary Sponsor: Hirotake Murakami
• Source(s) of Monetary Support: Meiji Seika Pharma Co., Ltd.