ArticleReproductive medicine and biology
A Multicenter Phase II Study on Photodynamic Therapy Using Talaporfin Sodium (ME2906) and a Semiconductor Laser (PNL6405CIN) for Intraepithelial Tumors of the Cervix.
Article in Reproductive medicine and biology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
13 authors.
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Abstract
Purpose: Conization for high-grade cervical intraepithelial neoplasia (CIN2-3) often harms obstetric outcomes. Photodynamic therapy (PDT) with talaporfin sodium provides a cervix-sparing alternative with short photosensitivity. We investigated the efficacy and safety of talaporfin-PDT for CIN2-3. Methods: We conducted a prospective, multicenter, single-arm phase II trial (jRCT2041190087) in women ≥ 20 years with biopsy-proven CIN2-3. Patients received talaporfin sodium (40 mg/m Results: Of 88 enrolled, 79 were treated and 77 (CIN2 = 7; CIN3 = 70; median age 32 years; 93.5% desiring future pregnancy) were evaluable. CR was achieved in all 77 (100%; lower 95% CI: 96.2%), including 95.8% in CIN3. High-risk HPV clearance occurred in 82.4%. One recurrence (1.3%) was observed. No serious adverse events occurred; four grade ≥ 3 events resolved. Cervical length was preserved. Eleven pregnancies occurred, yielding eight full-term deliveries. Conclusions: Talaporfin-PDT showed excellent efficacy, safety, and fertility preservation in CIN2-3, supporting its potential as a non-excisional alternative. Trial Registration: This study was registered in the Japan Registry of Clinical Trials (jRCT) under the identifier jRCT2041190087.
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